alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 864
Editorial Note: Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.

§ 864.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. ( a ) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.
( b ) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.
[52 FR 17732, May 11, 1987]
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.3030 Acetaminophen test system. ( a ) *Identification.* An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
( b ) *Classification.* Class II.
SIXTH DISTRICT COURT OF APPEAL

STATE OF FLORIDA

_____________________________

Case No. 6D23-309

Lower Tribunal No. CF20-003695-XX

_____________________________

ROBERTO L. RODRIGUEZ,

Appellant, 

v.

STATE OF FLORIDA,

Appellee.

_____________________________

Appeal from the Circuit Court for Polk County.

J. Kevin Abdoney, Judge.

February 13, 2024

PER CURIAM.

AFFIRMED.

WHITE, BROWNLEE and GANNAM, JJ., concur.

Howard L. “Rex” Dimmig, II, Public Defender, and Richard J. Sanders, Assistant Public 

Defender, Bartow, for Appellant.

Roberto L. Rodriguez, Crawfordville, pro se. 

Ashley Moody, Attorney General, Tallahassee, and Helene S. Parnes, Senior Assistant 

Attorney General, Tampa, for Appellee.

NOT FINAL UNTIL TIME EXPIRES TO FILE MOTION FOR REHEARING AND 

DISPOSITION THEREOF IF TIMELY FILED
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.4875 Intraluminal artery stripper. ( a ) *Identification.* An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
( b ) *Classification.* Class II (performance standards).
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.1130 Noninvasive blood pressure measurement system. ( a ) *Identification.* A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
( b ) *Classification.* Class II (performance standards).
# C_2014361EN.01001301.xml

| 13.10.2014 | EN | Official Journal of the European Union | C 361/13 |
| --- | --- | --- | --- |

13.10.2014

EN

Official Journal of the European Union

C 361/13

---

Action brought on 30 July 2014 — Laverana v OHIM (BIO MIT PFLANZENFLUID AUS EIGENER HERSTELLUNG)

(Case T-570/14)

2014/C 361/17

Language of the case: German

Parties

Parties

Applicant: Laverana GmbH & Co. KG (Wennigsen, Germany) (represented by J. Wachinger, M. Zöbisch and D. Chatterjee, lawyers)

Applicant:

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

Defendant:

Form of order sought

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 27 May 2014 in case R 124/2014-4; |
| --- | --- |

—

annul the decision of the Fourth Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 27 May 2014 in case R 124/2014-4;

| — | order the Office for Harmonisation in the Internal Market (Trade Marks and Designs) to pay the costs |
| --- | --- |

—

order the Office for Harmonisation in the Internal Market (Trade Marks and Designs) to pay the costs

Pleas in law and main arguments

Pleas in law and main arguments

Community trade mark concerned: Figurative mark which contains the word elements ‘BIO MIT PFLANZENFLUID AUS EIGENER HERSTELLUNG’ for goods and services in Classes 3, 5 and 35 — Community trade mark application No 1 1 9 22  581

Community trade mark concerned:

Decision of the Examiner: Refused the application

Decision of the Examiner:

Decision of the Board of Appeal: Dismissed the appeal

Decision of the Board of Appeal:

Pleas in law:

Pleas in law:

| — | Infringement of Article 7(1)(b) of Regulation No 207/2009; |
| --- | --- |

—

Infringement of Article 7(1)(b) of Regulation No 207/2009;

| — | Infringement of Article 7(1)(b) and (c) of Regulation No 207/2009; |
| --- | --- |

—

Infringement of Article 7(1)(b) and (c) of Regulation No 207/2009;

| — | Infringement of Article 7(1)(c) of Regulation No 207/2009; |
| --- | --- |

—

Infringement of Article 7(1)(c) of Regulation No 207/2009;

| — | Misuse of powers by a decision on the basis of competition policy considerations |
| --- | --- |

—

Misuse of powers by a decision on the basis of competition policy considerations

---
Editorial Note on Subpart A of Part 876
Editorial Note: Nomenclature changes to part 876 appear at 73 FR 35341, June 23, 2008.

§ 876.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. ( a ) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.
( b ) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.
[52 FR 17737, May 11, 1987]
Editorial Note on Part 874
Editorial Note: Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill. ( a ) *Identification.* An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.
( b ) *Classification.* Class II.
# C_2015381EN.01006002.xml

| 16.11.2015 | EN | Official Journal of the European Union | C 381/60 |
| --- | --- | --- | --- |

16.11.2015

EN

Official Journal of the European Union

C 381/60

---

Order of the General Court of 15 September 2015 — Souruh v Council

(Case T-599/14) (1)

1

(2015/C 381/80)

Language of the case: French

The President of the Seventh Chamber has ordered that the case be removed from the register.

---

(1)  OJ C 361, 13.10.2014.

1

---
SERVED: APRIL 3, 2014 

U.S. DEPARTMENT OF TRANSPORTATION 

OFFICE OF HEARINGS 

WASHINGTON, DC 

IN THE MATTER OF 

LEARJET, INC. 

DOCKET NO. FAA.;2014-0113 

(Civil Penalty Action) 

NOTICE OF ASSIGNMENT OF PROCEEDING 

This proceeding (heretofore designated as Case No. 2012CE430011) has been assigned to 

Administrative Law Judge Richard C. Goodwin. All future pleadings and other communications 

regarding this proceeding shall be served.on the Judge, the FAA Hearing Docket, and the other 

persons on the attached Service List. 

Attachment - Service List 

, . ...--····~--~·· ,,.r··"··········-.. ~-,, / . 

l ~ .... -~ ,.,.. 

R nnie A. Y ode{. . 

Chief Administra~~viiaw Judge 

(, _____ ..... 
The Honorable Richard C. Goodwin, Administrative Law Judge 

Office ofHearings, M-20 

U.S. Department of Transportation 

1200 New Jersey Avenue, S.E. (E11-310) 

Washington, DC 20590 

TEL: 202-366-5121 Staff Assistant 

FAX: 202-366-7536 
SERVICE LIST -BY U.S. MAIL 

ORIGINAL & ONE COPY 

Federal Aviation Administration 

800 Independence Avenue, S.W. 

Washington, DC 20591 

Attention: Hearing Docket Clerk, AGC-430 

Wilbur Wright Building-Suite 2W1 0001 

ONE COPY 

Mr. Ralph Acs, Vice President & General Manager 

Learjet, Inc., Respondent 

P.O. Box 7707 

Wichita, KS 67277-7707 

TEL: NOT PROVIDED 

FAX:' NOT PROVIDED 

Brenda R. Mesker, 

Director of Legal Services 

Learjet, Inc .. 

One Learjet Way 

Wichita, KS 67209 

TEL: NOT PROVIDED 

FAX: NOT PROVIDED 

Kenneth P. Quinn, Esquire, Respondent's Counsel 

Pillsbury Winthrop Shaw Pittman 

2300 N Street, NW 

Washington, DC 20037-1122 

TEL: 202-663-8000 

FAX: 202-663-8007 

David Kessler, Complainant's Counsel 

Federal Aviation Administration 

901 Locust, Room506 

Kansas City, MO 64106-2641 

TEL: 816-329-3763 

FAX: 816-329-3771 

Docket No. FAA-2014-0113 

(Civil Penalty Action) 

1 Service was by U.S. Mail. For service in person or by expedited courier, use the following address: Federal 

Aviation Administration, 600 Independence Avenue, S.W., Wilbur Wright Building-Suite 2W1000, Washington, 

DC 20591; Attention: Hearing Docket Clerk, AGC-430.
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.3630 Pacemaker generator function analyzer. ( a ) *Identification.* A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
( b ) *Classification.* Class II (performance standards).
# C_2014303EN.01005301.xml

| 8.9.2014 | EN | Official Journal of the European Union | C 303/53 |
| --- | --- | --- | --- |

8.9.2014

EN

Official Journal of the European Union

C 303/53

---

Action brought on 14 July 2014 — adp Gauselmann v OHIM (Multi Win)

(Case T-529/14)

2014/C 303/63

Language of the case: German

Parties

Parties

Applicant: adp Gauselmann GmbH (Espelkamp, Germany) (represented by P. Koch Moreno, lawyer)

Applicant:

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

Defendant:

Form of order sought

Form of order sought

The applicant claims that the Court should:

| — | annul the decision of the First Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 29 April 2014 in Case R 1326/2013-1; |
| --- | --- |

—

annul the decision of the First Board of Appeal of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) of 29 April 2014 in Case R 1326/2013-1;

| — | order OHIM to pay the costs. |
| --- | --- |

—

order OHIM to pay the costs.

Pleas in law and main arguments

Pleas in law and main arguments

Community trade mark concerned: Word mark ‘Multi Win’ for goods and services in Classes 9, 28 and 41 — Community trade mark application No 1 1 2 06  364

Community trade mark concerned:

Decision of the Examiner: Refused the application

Decision of the Examiner:

Decision of the Board of Appeal: Rejected the appeal

Decision of the Board of Appeal:

Pleas in law: Infringement of Article 7(1)(b) and (c) of Regulation No. 207/2009

Pleas in law:

---
[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9438-9439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4241]


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

DEPARTMENT OF LABOR

Employment and Training Administration

[TA-W-72,500]


Hardinge, Inc., Including On-Site Leased Workers of Manpower and 
Employment Solutions, Elmira, NY; Amended Certification Regarding 
Eligibility To Apply for Worker Adjustment Assistance

    In accordance with Section 223 of the Trade Act of 1974, as amended 
(``Act''), 19 U.S.C. 2273, the Department of Labor issued a 
Certification of Eligibility to Apply for Worker Adjustment Assistance 
on November 5, 2009, applicable to workers of Hardinge, Inc., including 
on-site leased workers from Manpower, Elmira, New York. The notice will 
be published in the Federal Register soon.
    At the request of the State Agency and company official, the 
Department reviewed the certification for workers of the subject firm. 
The workers are engaged in activities related to the production machine 
tools and accessory products.
    The company reports that on-site leased workers from Employment 
Solutions were employed on-site at the Elmira, New York location of 
Hardinge, Inc. The Department has determined that these workers were 
sufficiently under the control of the subject firm to be considered 
leased workers.
    Based on these findings, the Department is amending this 
certification to include workers leased from Employment Solutions, 
working on-site at the Elmira, New York location of Hardinge, Inc.
    The amended notice applicable to TA-W-72,500 is hereby issued as 
follows:

    All workers of Hardinge, Inc., Elmira, New York including on-
site leased workers from Manpower and Employment Solutions, who 
became totally or partially separated from

[[Page 9439]]

employment on or after September 29, 2008, through November 5, 2011, 
and all workers in the group threatened with total or partial 
separation from employment on date of certification through two 
years from the date of certification, are eligible to apply for 
adjustment assistance under Chapter 2 of Title II of the Trade Act 
of 1974, as amended.

    Signed in Washington, DC, this 4th day of February, 2010.
Richard Church,
Certifying Officer, Division of Trade Adjustment Assistance.
[FR Doc. 2010-4241 Filed 3-1-10; 8:45 am]
BILLING CODE 4510-FN-P
§ 573.696 Feed grade sodium formate. The food additive, feed grade sodium formate, may be safely used in the manufacture of complete swine and poultry feeds in accordance with the following prescribed conditions: ( a ) The additive is manufactured by the reaction of 99 percent formic acid and 50 percent sodium hydroxide in water to produce a solution made up of at least 20.5 percent sodium salt of formic acid and not more than 61 percent formic acid.
( b ) The additive is used or intended for use as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed.
( c ) To assure safe use of the additive, formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.
( d ) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: ( 1 ) The name of the additive.
( 2 ) Adequate directions for use, including a statement that feed grade sodium formate must be uniformly applied and thoroughly mixed into complete feeds and that the complete feeds so treated shall be labeled as containing feed grade sodium formate.
( 3 ) Cautions for use including this statement: Caution: Follow label directions. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination.
( e ) To assure safe use of the additive, in addition to the other information required by the act and paragraph (d) of this section, the label and labeling shall contain: ( 1 ) Appropriate warnings and safety precautions concerning feed grade sodium formate.
( 2 ) Statements identifying feed grade sodium formate as a corrosive and possible severe irritant.
( 3 ) Information about emergency aid in case of accidental exposure as follows: ( i ) Statements reflecting requirements of applicable sections of the Superfund Amendments and Reauthorization Act (SARA), and the Occupational Safety and Health Administration (OSHA) human safety guidance regulations.
( ii ) Contact address and telephone number for reporting adverse reactions or to request a copy of the Material Safety Data Sheet (MSDS).
[81 FR 67154, Sept. 30, 2016, as amended at 81 FR 95027, Dec. 27, 2016]
---

EXHIBIT 13.A



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 Amendment No. 2 to the Annual Report of Petaquilla Minerals Ltd. (the Company) on Form 20-F for the transition period ended May 31, 2008, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Joao Manuel , President and Chief Executive 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), as applicable, of the Securities Exchange Act of 1934, as amended; and



2.

The information contained in the Report fairly presents, in all materials respects, the financial condition and results of operations of the Company.





|                              | 
|----------------------------- | 
|/s/ Joao Manuel               | 
|Joao Manuel                   | 
|(principal executive officer) | 



Dated:  November 6, 2009





The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.





---
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.5240 Medical adhesive tape and adhesive bandage. ( a ) *Identification.* A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
( 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 § 880.9.
[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001]
NOTE: This order is nonprecedential. 

Wniteb ~tate~ (!Court of §ppeaI~ 

for tbe jfeberaI (!Cirroit 

IN RE FRED T. PARKER 

2011-1421 

(Serial No. 09/815,567) 

Appeal from the United States Patent and Trademark 

Office, Board of Patent Appeals and Interferences. 

ON MOTION 

ORDER 

The Director of the United States Patent and Trademark Office moves for a 43-day extension of time, until 

February 29, 2012, to file its response brief. 

Upon consideration thereof, 

IT Is ORDERED THAT: 

The motion is granted. No further extensions should 

be anticipated. 
INREPARKER 

JAN 1? 2012 

Date 

cc: Janet Pioli, Esq. 

Raymond T. Chen, Esq. 

s21 

FOR THE COURT 

lsi Jan Horbaly 

Jan Horbaly 

Clerk 

2 

FILED 

u.s. COURT OF APPEALS FOR 

THE FEDERAL CIRCUIT 

JAN 1 72012 

JAN HORBAl.Y 

CLERK