alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
§ 876.1075 Gastroenterology-urology biopsy instrument. ( a ) *Identification.* A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
( b ) *Classification.* ( 1 ) Class II (performance standards).
( 2 ) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
This schedule contains summary financial information extracted from the
consolidated balance sheets and statements of consolidated operations and
accumulated deficit on pages 37 and 38 of the Company's Form 10-K for the year
ended December 31, 1998, and is qualified in entirety by reference to such
financial statements.
</LEGEND>
       
<S>                             <C>
<PERIOD-TYPE>                   YEAR
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-END>                               DEC-31-1998
<CASH>                                          38,147
<SECURITIES>                                    19,643
<RECEIVABLES>                                    6,562
<ALLOWANCES>                                         0
<INVENTORY>                                      1,316
<CURRENT-ASSETS>                                66,425
<PP&E>                                         189,466
<DEPRECIATION>                                     232
<TOTAL-ASSETS>                                 279,900
<CURRENT-LIABILITIES>                           12,357
<BONDS>                                        110,000
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                       222,447
<OTHER-SE>                                       3,093
<TOTAL-LIABILITY-AND-EQUITY>                   279,900
<SALES>                                             16
<TOTAL-REVENUES>                                 3,797
<CGS>                                              942
<TOTAL-COSTS>                                  137,788
<OTHER-EXPENSES>                                  (97)
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                              (136,695)
<INCOME-TAX>                                  (45,718)
<INCOME-CONTINUING>                           (90,977)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                  (90,199)
<EPS-PRIMARY>                                   (2.49)
<EPS-DILUTED>                                   (2.49)
        

</TABLE>
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
This schedule contains summary financial information extracted from the
balance sheets and statements of operations found on page 2 and 4 of the
Company's Form 10-Q for the year to date, and is qualified in its entirety by
reference to such financial statements.
</LEGEND>                               
<PERIOD-TYPE>                   3-MOS
<FISCAL-YEAR-END>                        DEC-31-1996
<PERIOD-END>                             MAR-31-1997
<CASH>                                        526129
<SECURITIES>                                 3940001
<RECEIVABLES>                                 836715
<ALLOWANCES>                                       0
<INVENTORY>                                  1056145
<CURRENT-ASSETS>                             7150231
<PP&E>                                       2515093
<DEPRECIATION>                                     0
<TOTAL-ASSETS>                              11855782
<CURRENT-LIABILITIES>                        1031143
<BONDS>                                            0
<COMMON>                                    11538989
<PREFERRED-MANDATORY>                              0
<PREFERRED>                                        0
<OTHER-SE>                                   (879453)
<TOTAL-LIABILITY-AND-EQUITY>                11855782 
<SALES>                                      3339613
<TOTAL-REVENUES>                             3339613
<CGS>                                        2349861
<TOTAL-COSTS>                                2349861
<OTHER-EXPENSES>                              995844
<LOSS-PROVISION>                                   0
<INTEREST-EXPENSE>                                 0
<INCOME-PRETAX>                                49101
<INCOME-TAX>                                   20623
<INCOME-CONTINUING>                            28478
<DISCONTINUED>                                     0
<EXTRAORDINARY>                                    0
<CHANGES>                                          0
<NET-INCOME>                                   28478
<EPS-PRIMARY>                                      0
<EPS-DILUTED>                                      0

</TABLE>
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. ( a ) *Identification.* A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Appropriate testing to characterize the electrical output specifications of the device (*i.e.,* total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted.
( 2 ) Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
( 3 ) All elements of the device that may contact the patient must be assessed to be biocompatible.
( 4 ) Labeling must include: ( i ) Validated instructions which addresses the following: ( A ) Identification of areas of the body which are appropriate and not appropriate for contact with the device.
( B ) Whether use of the device in conjunction with flammable materials (*e.g.,* insect repellent) is appropriate.
( C ) Use of the device on or near implanted devices.
( D ) How to identify the correct type of skin condition.
( ii ) Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration).
( iii ) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device.
( iv ) The anticipated number of device uses prior to failure.
[80 FR 15165, Mar. 23, 2015]
EXHIBIT 32

                            CERTIFICATION PURSUANT TO
                             18 U.S.C. SECTION 1350,
                             AS ADOPTED PURSUANT TO
                  SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of GVC Venture Corp. (the "Company") on
Form 10-QSB for the quarter ended December 31, 2004, as filed with the
Securities and Exchange Commission on the date hereof (the "Report"), I, Bernard
Zimmerman, Principal Executive Officer and Principal Financial Officer of the
Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 that, to the best of my knowledge:

     (1)  The Report fully complies with the requirements of Section 13(a) or
          15(d) of the Securities Exchange Act of 1934; and

     (2)  The information contained in the report fairly presents, in all
          material respects, the financial condition and results of operations
          of the Company.

February 4, 2005


                                              /s/ Bernard Zimmerman
                                              ----------------------------------
                                              Bernard Zimmerman, President
                                              (Principal Executive Officer) and
                                              Treasurer (Principal Financial and
                                              Accounting Officer)
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.4300 Implantable clip. ( a ) *Identification.* An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
( b ) *Classification.* Class II.
IN THE DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA

FIFTH DISTRICT

NOT FINAL UNTIL TIME EXPIRES TO

FILE MOTION FOR REHEARING AND

DISPOSITION THEREOF IF FILED

LEROY WILLIAMS, III,

Appellant,

v. Case No. 5D22-2284

LT Case No. 2009-CF-1232-A

STATE OF FLORIDA,

Appellee.

________________________________/

Decision filed February 7, 2023

3.850 Appeal from the Circuit Court 

for Seminole County,

Donna L. Mcintosh, Judge.

Leroy Williams, III, Perry, pro se.

No Appearance for Appellee.

PER CURIAM.

AFFIRMED.

LAMBERT, C.J., EVANDER and HARRIS, JJ., concur.
#### § 810.1 Scope.

Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.
EXHIBIT 99.1

        Certification Pursuant to Section 1350 of Chapter 63 of Title 18
                            of the United States Code

      I, Thomas M.  O'Flynn,  Chief  Financial  Officer of PSEG Energy  Holdings
L.L.C.  (the  "Company"),  to the  best of my  knowledge,  certify  that (i) the
Quarterly Report of the Company on Form 10-Q for the Quarter ended September 30,
2002 (the "Periodic  Report") fully  complies with the  requirements  of Section
13(a) or 15(d) of the Securities  Exchange Act of 1934 and (ii) the  information
contained in the Periodic Report fairly presents, in all material respects,  the
financial condition and results of operations of the Company.

                                              /s/ Thomas M. O'Flynn
                                              ----------------------------------
                                              Thomas M. O'Flynn
                                              Chief Financial Officer
                                              November 1, 2002
§ 522.970 Flunixin. ( a ) *Specifications.* Each milliliter of solution contains flunixin meglumine equivalent to 50 milligrams (mg) flunixin.
( b ) *Sponsors.* See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. ( 1 ) See Nos. 000061, 055529, 058198, and 061133 for use as in paragraph (e) of this section.
( 2 ) See No. 054771 for use as in paragraph (e)(1) of this section.
( 3 ) See No. 016592 for use as in paragraphs (e)(1) and (e)(2) of this section.
( c ) *Related tolerances.* See § 556.286 of this chapter.
( d ) *Special considerations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
( e ) *Conditions of use* — ( 1 ) *Horses* — ( i ) *Amount.* 0.5 mg per pound (/lb) of body weight per day, intravenously or intramuscularly, for up to 5 days.
( ii ) *Indications for use.* For alleviation of inflammation and pain associated with musculoskeletal disorders, and alleviation of visceral pain associated with colic.
( iii ) *Limitations.* Do not use in horses intended for human consumption.
( 2 ) *Cattle* — ( i ) *Amounts and indications for use* — ( A ) Administer 1.1 to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day intravenously, as a single dose or divided into two doses administered at 12-hour intervals, for up to 3 days for control of pyrexia associated with bovine respiratory disease and endotoxemia or for control of inflammation in endotoxemia.
( B ) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once intravenously for control of pyrexia associated with acute bovine mastitis.
( ii ) *Limitations.* Approved only for intravenous administration in cattle. Intramuscular administration has resulted in violative residues in the edible tissues of cattle sent to slaughter. Cattle must not be slaughtered for human consumption within 4 days of last treatment. Milk that has been taken during treatment and for 36 hours after the last treatment must not be used for food. Do not use in dry dairy cows. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. ( B ) [Reserved]
( 3 ) *Swine* — ( i ) *Amount.* Administer 2.2 mg/kg (1.0 mg/lb) of body weight as a single intramuscular injection.
( ii ) *Indications for use.* For the control of pyrexia associated with swine respiratory disease.
( iii ) *Limitations.* Swine must not be slaughtered for human consumption within 12 days of last treatment.
[42 FR 39103, Aug. 2, 1977, as amended at 52 FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, Dec. 8, 2010; 79 FR 16189, Mar. 25, 2014; 82 FR 43484, Sept. 18, 2017; 86 FR 57997, Oct. 20, 2021]
<TABLE> <S> <C>

<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM  THE
COMPANY'S CONSOLIDATED FINANCIAL STATEMENTS OF INCOME AND CONSOLIDATED
BALANCE SHEETS AND IS QUALIFIED BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
       
<S>                             <C>
<PERIOD-TYPE>                   6-MOS
<FISCAL-YEAR-END>                          MAR-31-1997
<PERIOD-END>                               SEP-27-1997
<CASH>                                           21598
<SECURITIES>                                         0
<RECEIVABLES>                                     2080
<ALLOWANCES>                                      3157
<INVENTORY>                                      92623
<CURRENT-ASSETS>                                186144
<PP&E>                                           10504
<DEPRECIATION>                                    6035
<TOTAL-ASSETS>                                  195105
<CURRENT-LIABILITIES>                           133768
<BONDS>                                              0
<PREFERRED-MANDATORY>                                0
<PREFERRED>                                          0
<COMMON>                                             6
<OTHER-SE>                                      195099
<TOTAL-LIABILITY-AND-EQUITY>                    195105
<SALES>                                         181886
<TOTAL-REVENUES>                                181886
<CGS>                                           162087
<TOTAL-COSTS>                                   162087
<OTHER-EXPENSES>                                 15166
<LOSS-PROVISION>                                  1768
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                                   5293
<INCOME-TAX>                                      1985
<INCOME-CONTINUING>                               3308
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                      3308
<EPS-PRIMARY>                                      .59
<EPS-DILUTED>                                      .58
        

</TABLE>
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.4030 Skull plate anvil. ( a ) *Identification.* A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.
( 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 § 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38808, July 25, 2001]
# C_2016402EN.01003702.xml

| 31.10.2016 | EN | Official Journal of the European Union | C 402/37 |
| --- | --- | --- | --- |

31.10.2016

EN

Official Journal of the European Union

C 402/37

---

Judgment of the General Court of 15 September 2016 — European Dynamics Luxembourg and Evropaïki Dynamiki v EIT

(Case T-481/14) (1)

1

((Public service contracts - Tender procedure - Supply of services for the development of a knowledge and information management platform - Software development services and maintenance of availability and efficiency of computer services - Refusal to rank the applicants in first place - Selection criteria - Award criteria - Obligation to state reasons - Manifest errors of assessment - Access to documents - Non-contractual liability))

(2016/C 402/41)

Language of the case: English

Parties

Parties

Applicants: European Dynamics Luxembourg SA (Ettelbrück, Luxembourg) and Evropaïki Dynamiki — Proigmena Systimata Tilepikoinonion Pliroforikis kai Tilematikis AE (Athens, Greece) (represented initially by E. Siouti and M. Sfyri, and subsequently by M. Sfyri and A. Lymperopoulou, lawyers)

Applicants:

Defendant: European Institute of Innovation and Technology (represented initially by M. Kern, B. Győri-Hartwig and P. Juanes Burgos, and subsequently by B. Győri-Hartwig and P. Juanes Burgos, acting as Agents, assisted by P. Wytinck and B. Hoorelbeke, lawyers)

Defendant:

Re:

Re:

Application, firstly, on the basis of Article 263 TFEU for annulment of the EIT’s decision of 14 April 2014 ranking the tender submitted by the applicants in the context of an invitation to tender relating to computer and related services in second place, and for annulment of the EIT’s letter of 25 April 2014 by which it refused to communicate the names of the members of the evaluation committee and, secondly, on the basis of Article 168 TFEU, for damages.

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Dismisses the action; |
| --- | --- |

1.

Dismisses the action;

| 2. | Orders European Dynamics Luxembourg SA and Evropaïki Dynamiki — Proigmena Systimata Tilepikoinonion Pliroforikis kai Tilematikis AE to pay the costs. |
| --- | --- |

2.

Orders European Dynamics Luxembourg SA and Evropaïki Dynamiki — Proigmena Systimata Tilepikoinonion Pliroforikis kai Tilematikis AE to pay the costs.

---

(1)  OJ C 351, 6.10.2014.

1

---
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Page 10845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4933]


=======================================================================
-----------------------------------------------------------------------

SMALL BUSINESS ADMINISTRATION

[Disaster Declaration <greek-i> 12057 and <greek-i> 12058]


North Dakota Disaster <greek-i> ND-00019

AGENCY: U.S. Small Business Administration.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is a Notice of the Presidential declaration of a major 
disaster for Public Assistance Only for the State of North Dakota 
(FEMA--1879--DR), dated 02/26/2010.
    Incident: Severe Winter Storm.
    Incident Period: 01/20/2010 through 01/25/2010.
    Effective Date: 02/26/2010.
    Physical Loan Application Deadline Date: 04/27/2010.
    Economic Injury (EIDL) Loan Application Deadline Date: 11/26/2010.

ADDRESSES: Submit completed loan applications to: U.S. Small Business 
Administration, Processing and Disbursement Center, 14925 Kingsport 
Road, Fort Worth, TX 76155.

FOR FURTHER INFORMATION CONTACT: A. Escobar, Office of Disaster 
Assistance, U.S. Small Business Administration, 409 3rd Street, SW., 
Suite 6050, Washington, DC 20416.

SUPPLEMENTARY INFORMATION: Notice is hereby given that as a result of 
the President's major disaster declaration on 02/26/2010, Private Non-
Profit organizations that provide essential services of governmental 
nature may file disaster loan applications at the address listed above 
or other locally announced locations.
    The following areas have been determined to be adversely affected 
by the disaster:

Primary Counties:
    Adams, Barnes, Billings, Bowman, Burke, Dickey, Dunn, Emmons, 
Golden Valley, Grant, Hettinger, Logan, McIntosh, McKenzie, Mercer, 
Morton, Mountrail, Oliver, Ransom, Renville, Sioux, Slope, Stark, 
Steele, Walsh, and the Standing Rock Indian Reservation.

    The Interest Rates are:

------------------------------------------------------------------------
                                                                Percent
------------------------------------------------------------------------
For Physical Damage:                                           .........
    Non-Profit Organizations With Credit Available Elsewhere.      3.625
    Non-Profit Organizations Without Credit Available              3.000
     Elsewhere...............................................
For Economic Injury:                                           .........
    Non-Profit Organizations Without Credit Available              3.000
     Elsewhere...............................................
------------------------------------------------------------------------

    The number assigned to this disaster for physical damage is 12057B 
and for economic injury is 12058B.

(Catalog of Federal Domestic Assistance Numbers 59002 and 59008)

James E. Rivera,
Associate Administrator for Disaster Assistance.
[FR Doc. 2010-4933 Filed 3-8-10; 8:45 am]
BILLING CODE 8025-01-P
Editorial Note on Part 866
Editorial Note: Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.

§ 866.5800 Seminal fluid (sperm) immunological test system. ( a ) *Identification.* A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes.
( 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 § 866.9.
[54 FR 25047, June 12, 1989, as amended at 66 FR 38793, July 25, 2001]