alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 876.5025 Vibrator for climax control of premature ejaculation. ( a ) *Identification.* A vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.
( b ) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special controls for this device are: ( 1 ) The labeling must include specific instructions regarding the proper placement and use of the device.
( 2 ) The portions of the device that contact the patient must be demonstrated to be biocompatible.
( 3 ) Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.
( 4 ) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
[80 FR 30355, May 28, 2015, as amended at 84 FR 71814, Dec. 30, 2019]
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1560 Urinary phenylketones (nonquantitative) test system. ( a ) *Identification.* A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]
#### § 814.80 General.

A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.3135 *Coccidioides immitis* serological reagents. ( a ) *Identification. Coccidioides immitis* serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to *Coccidioides immitis* in serum. The identification aids in the diagnosis of coccidioidomycosis caused by a fungus belonging to the genus *Coccidioides* and provides epidemiological information on diseases caused by this microorganism. An infection with *Coccidioides immitis* produces symptoms varying in severity from those accompanying the common cold to those of influenza.
( b ) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59226, Nov. 3, 1998]
§ 820.20 Management responsibility. ( a ) *Quality policy.* Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.
( b ) *Organization.* Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part. ( 1 ) *Responsibility and authority.* Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
( 2 ) *Resources.* Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
( 3 ) *Management representative.* Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: ( i ) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
( ii ) Reporting on the performance of the quality system to management with executive responsibility for review.
( c ) *Management review.* Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.
( d ) *Quality planning.* Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.
( e ) *Quality system procedures.* Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.
# C_2014129EN.01003401.xml

| 28.4.2014 | EN | Official Journal of the European Union | C 129/34 |
| --- | --- | --- | --- |

28.4.2014

EN

Official Journal of the European Union

C 129/34

---

Action brought on 17 February 2014 — BSH Bosch und Siemens Hausgeräte v OHIM — Arçelik (AquaPerfect)

(Case T-123/14)

(2014/C 129/41)

Language in which the application was lodged: English

Parties

Applicant: BSH Bosch und Siemens Hausgeräte GmbH (Munich, Germany) (represented by: S. Biagosch, lawyer)

Defendant: Office for Harmonisation in the Internal Market (Trade Marks and Designs)

Other party to the proceedings before the Board of Appeal: Arçelik AS (Istanbul, Turkey)

Form of order sought

The applicant claims that the Court should:

| — | Annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 9 December 2013 given in Case R 314/2013-4; |
| --- | --- |

—

Annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 9 December 2013 given in Case R 314/2013-4;

| — | Order the defendant to pay the costs of proceedings. |
| --- | --- |

—

Order the defendant to pay the costs of proceedings.

Pleas in law and main arguments

Applicant for a Community trade mark: The other party to the proceedings before the Board of Appeal

Community trade mark concerned: The word mark ‘AquaPerfect’ for the goods in Class 7 — Community trade mark application No 10 330 454

Proprietor of the mark or sign cited in the opposition proceedings: The applicant

Mark or sign cited in opposition: Community registration No 9 444 118 of the word mark ‘waterPerfect’ for goods in Class 7

Decision of the Opposition Division: Partly upheld the opposition

Decision of the Board of Appeal: Annulled the contested decision and rejected the opposition

Pleas in law: Infringement of Article 8(1)(b) CTMR.

---
#### Drake et al. *v.*Everson.

[No. 19,120.

Filed June 8, 1900.]

Appeal and Error.— *Record.*— Evidence.—Time *of*Tiling.— *Act of*1899.— Under the provision of the act of 1899 (Acts 1899, p. 384) that the transcript of the evidence shall be filed with the clerk within a time fixed by the court trying such cause, the court must act while the cause is before it, and when the time granted had expired, with nothing done, it was too late at the next term of court to fix a time within which the transcript of the evidence might be filed, as the cause was no longer *in fieri.*

Erom the Hancock Circuit Court.

*Affirmed.*

*David Smith, B. L. Mason*and *U. S. Jackson,*for appellants.

*E. Marsh*and *W. W. Cook,*for appellee.

*48Baker, C. J.

— The only error assigned and not waived is that the court erred in overruling the motion for a new trial. In support of the motion, the only contention made is that the evidence is insufficient. Appellee insists that the evidence is not in the record. The motion was overruled on April 13, 1899, the fifty-eighth day of the February term, and sixty days time was then given appellants in which to file their bill of exceptions. Nothing was done until September 25, 1899, the nineteenth day of the September term. On that day the following order-book entry was made: “Come the parties by their attorneys, and thereupon the official reporter of this court is ordered to file a transcript of the evidence in this cause by the 26th day of September, 1899.” On the same day the reporter’s transcript of the evidence was filed in the clerk’s office. On September 27th appellants presented the transcript of the evidence to the judge and requested him to certify that it was correct and contained all the evidence; and the judge made such a certificate upon the transcript. Appellants claim that under the law of 1899 (Acts 1899 p. 384), the evidence is in the record of this appeal. It is unnecessary to examine the statute of 1899 in any other respect than to the time within which the transcript of the evidence must be filed in the clerk’s office. The act provides that “The transcript of the evidence so prepared by such reporter shall be filed by him with the clerk of the court wherein such cause is tried, within a time to be fixed by the court trying such cause.” Though the act does not say when the court shall make the order fixing the time, it is plain that the court must act while the cause is yet before it. On April 13, 1899, it was proper to give time, as was done. But after the time then granted had expired with nothing done, it was too late at the September term to fix a new time within which the transcript of the evidence might be filed, as the cause was no longer in *fieri. Utterback*v. *State,*153 Ind. 545.

Judgment affirmed.
# C_2015381EN.01003101.xml

| 16.11.2015 | EN | Official Journal of the European Union | C 381/31 |
| --- | --- | --- | --- |

16.11.2015

EN

Official Journal of the European Union

C 381/31

---

Order of the General Court of 16 September 2015 — VSM Geneesmiddelen v Commission

(Case T-578/14) (1)

1

((Action for failure to act and for annulment - Consumer protection - Health claims relating to food - Regulation (EC) No 1924/2006 - Botanical substances - Time-limit for bringing proceedings - No interest in bringing proceedings - Non-actionable measure - Inadmissibility))

(2015/C 381/34)

Language of the case: English

Parties

Parties

Applicant: VSM Geneesmiddelen BV (Alkmaar, Netherlands) (represented by: U. Grundmann, lawyer)

Applicant:

Defendant: European Commission (represented initially by J. Enegren and subsequently by M. Wilderspin and S. Grünheid, acting as Agents)

Defendant:

Re:

Re:

Application for a declaration that the Commission failed to act in that it unlawfully failed to instruct the European Food Safety Authority (EFSA) to assess health claims relating to botanical substances as a precondition for the adoption of the definitive list of permitted claims in accordance with Article 13(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9) and, in the alternative, an application for annulment of the decision purportedly contained in the Commission’s letter of 19 June 2014 refusing to instruct the EFSA to assess those claims.

Operative part of the order

Operative part of the order

| 1. | The action is dismissed as inadmissible. |
| --- | --- |

1.

The action is dismissed as inadmissible.

| 2. | VSM Geneesmiddelen BV is ordered to pay the costs. |
| --- | --- |

2.

VSM Geneesmiddelen BV is ordered to pay the costs.

---

(1)  OJ C 339, 29.9.2014.

1

---
FIRST DISTRICT COURT OF APPEAL

STATE OF FLORIDA

_____________________________

No. 1D17-3110

_____________________________

JUAN FRANCISCO VEGA and

JAMAAL ALI BILAL,

Appellants,

v.

MIKE CARROLL, Secretary, 

Florida Department of Children

and Families,

Appellee.

_____________________________

On appeal from the Division of Administrative Hearings.

J. Bruce Culpepper, Administrative Law Judge.

September 27, 2018

PER CURIAM.

AFFIRMED.

ROBERTS, RAY, and KELSEY, JJ., concur.
2

_____________________________

Not final until disposition of any timely and 

authorized motion under Fla. R. App. P. 9.330 or 

9.331.

_____________________________

Juan Francisco Vega, pro se, and Jamaal Ali Bilal, pro se, 

Appellants.

Pamela Jo Bondi, Attorney General, and Karen A. Brodeen,

Assistant Attorney General, Tallahassee, for Appellee.
Editorial Note on Part 868
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.

§ 868.5420 Ether hook. ( a ) *Identification.* An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.
( b ) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]
§ 876.5320 Nonimplanted electrical continence device. ( a ) *Identification.* A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).
( b ) *Classification.* Class II (performance standards).
§ 876.5270 Implanted electrical urinary continence device. ( a ) *Identification.* An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.
( b ) *Classification.* Class III (premarket approval).
( c ) *Date PMA or notice of completion of a PDP is required.* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any implanted electrical urinary continence device that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an implanted electrical urinary continence device that was in commercial distribution before May 28, 1976. Any other implanted electrical urinary continence device shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996]
<PAGE>
 
     Page 1

Exhibit 15    Letter re:  Unaudited Interim Financial Information
                          ---------------------------------------

FMC Gold Company
Chicago, Illinois

Gentlemen:

Re:  Registration Statements No. 33-35804 and No. 33-35805 on Form S-3.

With respect to the subject registration statements, we acknowledge our
awareness of the incorporation by reference of our report dated October 16, 1995
related to our review of interim financial information.

Pursuant to Rule 436(c) under the Securities Act of 1933, such report is not
considered a part of a registration statement prepared or certified by an
accountant or a report prepared or certified by an accountant within the meaning
of Sections 7 and 11 of the Act.

Very truly yours,



KPMG Peat Marwick LLP

Salt Lake City, Utah
November 9, 1995
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.5310 Automated external defibrillator system. ( a ) *Identification.* An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (*e.g.,* battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
( b ) *Classification.* Class III (premarket approval)
( c ) *Date PMA or notice of completion of PDP is required.* A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[68 FR 61344, Oct. 28, 2003; 69 FR 10615, Mar. 8, 2004, as amended at 80 FR 5682, Feb. 3, 2015]
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET AND THE STATEMENTS OF REVENUE AND EXPENSES AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH REPORT ON FORM 10-K.
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
<PERIOD-START>                             JAN-01-1999
<PERIOD-END>                               MAR-31-1999
<CASH>                                       2,863,315
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                                     0
<PP&E>                                               0
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<TOTAL-ASSETS>                               4,525,847
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<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             0
<OTHER-SE>                                   4,419,943
<TOTAL-LIABILITY-AND-EQUITY>                 4,525,847
<SALES>                                              0
<TOTAL-REVENUES>                                32,031
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                                68,422
<LOSS-PROVISION>                              (24,175)
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                                      0
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                 (161,815)
<EPS-PRIMARY>                                        0
<EPS-DILUTED>                                        0
        

</TABLE>
<PAGE>





                                      EXHIBIT 11

                           PENN TREATY AMERICAN CORPORATION
                          COMPUTATION OF EARNINGS PER SHARE
                                     (unaudited)
<TABLE>
<CAPTION>

                                             Three months                Nine months 
                                           ended September 30,        ended September 30,
                                          -----------------------   ----------------------
                                          1996 (1)      1995 (1)      1996 (1)     1995 (1)
                                          -----------------------   ----------------------
<S>                                       <C>           <C>           <C>          <C>
Shares outstanding
    beginning of period                  7,009,447     4,671,284     6,971,284    4,671,284 

Weighted average shares issued during
     the public offering                         -     2,065,217                     695,971

Weighted average shares of
     exercised stock options               169,529             -        86,033             -
                                          -----------  ----------   -------------  -----------

Weighted average primary
     shares outstanding                  7,178,976     6,736,501     7,057,317     5,367,255

Net income for primary
     earnings per share                  3,097,501     2,342,834     8,673,491     6,148,235

Net income per common
     primary share                         $   0.43      $   0.35      $   1.23      $   1.15
                                          -----------  ----------   -------------  -----------

</TABLE>


(1) Shares outstanding at the beginning of the period are net of Treasury
    Shares held at January 1, 1996 and 1995 of 605,629
§ 812.19 Address for IDE correspondence. ( a ) If you are sending an application, supplemental application, report, request for waiver, request for import or export approval, or other correspondence relating to matters covered by this part, you must send the submission to the appropriate address as follows: ( 1 ) For devices regulated by the Center for Devices and Radiological Health, send it to the current address displayed on the website *https://www.fda.gov/cdrhsubmissionaddress .*
( 2 ) For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website *https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm .*
( 3 ) For devices regulated by the Center for Drug Evaluation and Research, send it to Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.
( b ) You must state on the outside wrapper of each submission what the submission is, for example, an “IDE application,” a “supplemental IDE application,” or a “correspondence concerning an IDE (or an IDE application).”
[71 FR 42048, July 25, 2006, as amended at 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019]