alea-institute/kl3m-data-sample-004-shuffled huggingface dataset:
Editorial Note on Part 878
Editorial Note: Nomenclature changes to part 878 appear at 73 FR 35341, June 23, 2008.

§ 878.4800 Manual surgical instrument for general use. ( a ) *Identification.* A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
( 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 § 878.9.
[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001; 86 FR 56204, Oct. 8, 2021; 86 FR 66188, Nov. 22, 2021]
#### § 640.73 Reporting of fatal donor reactions.

If a donor has a fatal reaction which, in any way, may be associated with plasmapheresis the Director of the Center for Biologics Evaluation and Research shall be notified by telephone as soon as possible. If the facility is located outside of the continental United States, notification by cable or telegram shall be acceptable.

[41 FR 10770, Mar. 12, 1976, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]
#### NIAGARA SPRAYER CO. *v.*WOOD.

1. Appeal and Error — Record — Exceptions — Assignments oe Error — Index.

The Supreme Court, on error to the trial of an action at law before the court sitting without a jury, will not review assignments of error relating to the admission or rejection of testimony if the record does not conform to Supreme Court Rule 36 by containing an index of the place where such exceptions are to be found, the omission not being supplied in the brief for appellant, which also contained no argument addressed to such assignments of error.

2. Same — Record—Bill of Exceptions.

The objection of appellant to the size of the record on appeal, claiming that the opposite party had added unnecessarily to thé length of the proposed bill of exceptions by his amendments, cannot be considered in the absence of some showing or information as to the number of pages which were added unduly and no objection appearing to the action of the trial court in amending the record.

Error to Oceana; Sullivan, J., presiding.

Sub*304mitted April 7, 1915.

(Docket No. 10.)

Decided June 7, 1915.

Assumpsit by Niagara Sprayer Company against Susie M. Wood upon a promissory note. There was a claim of recoupment. Judgment for defendant. Plaintiff brings error.

Affirmed.

*F. E. Wetmore,*for appellant.

*A. S. Hinds,*for appellee.

Per Curiam.

The action is assumpsit. The trial was before the court without a jury. Findings of fact and law were made and filed. These the plaintiff moved to amend and the motion was denied. There are 14 assignments of error, 4 of which relate to rulings admitting or rejecting testimony. The index to the record does not show where the exceptions (if there were exceptions) upon which these are predicated may be found in the record. Nor is the omission supplied in the brief for appellant, nor is there argument addressed to these assignments.

This court has sometimes, as matter of grace, assumed the labor of looking up the exceptions in the record. *Mills*v. *Warner,*167 Mich. 619 (133 N. W. 494); *Yanelli*v. *Littlejohn,*172 Mich. 91 (137 N. W. 723). It has refused to consider such assignments. *Duff*v. *Judson,*160 Mich. 386, 391 (125 N. W. 371). Supreme Court Rule 36 is not ambiguous, and would seem- to have been frequently enough pressed upon the attention of counsel.

All other assignments of error are addressed to the findings. None of them alleges that the findings of fact are not supported by some testimony, nor that the facts found do not support the conclusions of law. There is therefore nothing for this court to review. See Circuit Court Rule 26 and Stevens’ notes thereto *305and the large number of similar rulings made since those notes were published.

The judgment is affirmed. Appellant, in the brief, objects to the size of the record, complaining that much of it is unnecessary and was added to his proposed bill of exceptions on motion of appellee. The record appears to be much too large, but we are not referred to any page thereof where appellant’s objections to amending it are to be found, and cannot separate the bill of exceptions it proposed from the bill as settled.
# C_2015155EN.01003901.xml

| 11.5.2015 | EN | Official Journal of the European Union | C 155/39 |
| --- | --- | --- | --- |

11.5.2015

EN

Official Journal of the European Union

C 155/39

---

Order of the General Court of 16 March 2015 — egeplast international v Commission

(Case T-291/14) (1)

1

(2015/C 155/50)

Language of the case: German

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

---

(1)  OJ C 223, 14.7.2014.

1

---
Editorial Note on Part 870
Editorial Note: Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

§ 870.3600 External pacemaker pulse generator. ( a ) *Identification.* An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
( 2 ) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (*i.e.,* battery power, AC mains connections, or both).
( 3 ) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: ( i ) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
( ii ) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
( iii ) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (*e.g.* data storage, printing), and indicator(s) functionality under intended use conditions; and
( iv ) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
( 4 ) Appropriate software verification, validation, and hazard analysis must be performed.
( 5 ) Labeling must include the following: ( i ) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
( ii ) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
( iii ) The labeling must list all pacing modes available in the device;
( iv ) Labeling must include a detailed description of any special capabilities (*e.g.,* overdrive pacing or automatic mode switching); and
( v ) Appropriate electromagnetic compatibility information must be included.
[81 FR 22529, Apr. 18, 2016]
Editorial Note on Part 880
Editorial Note: Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.

§ 880.6990 Infusion stand. ( a ) *Identification.* The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.
( 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.
[63 FR 59718, Nov. 5, 1998]
I 

118TH CONGRESS 

2D SESSION H. R. 7899 

To direct the Attorney General, in consultation with the Secretary of Health 

and Human Services, to promulgate the final regulations relating to 

special registration for telemedicine. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 9, 2024 

Mr. EZELL introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each 

case for consideration of such provisions as fall within the jurisdiction of 

the committee concerned 

A BILL 

To direct the Attorney General, in consultation with the 

Secretary of Health and Human Services, to promulgate 

the final regulations relating to special registration for 

telemedicine. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. REGULATIONS RELATING TO SPECIAL REG4 ISTRATION FOR TELEMEDICINE. 

5 Not later than 1 year after the date of enactment 

6 of this Act, the Attorney General, in consultation with the 

7 Secretary of Health and Human Services, shall promulVerDate Sep 11 2014 03:06 Apr 17, 2024 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7899.IH H7899

kjohnson on DSK7ZCZBW3PROD with $$_JOB
2 

•HR 7899 IH

1 gate the final regulations required under section 311(h)(2) 

2 of the Controlled Substances Act (21 U.S.C. 831(h)(2)). 

Æ 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
_______________________________________ __ Michigan Supreme Court 

# Order

Lansing, Michigan



### June 26, 2007 Clifford W. Taylor, Chief Justice

Michael F. Cavanagh Elizabeth A. Weaver 

### 132671 Marilyn Kelly Maura D. Corrigan Robert P. Young, Jr. Stephen J. Markman, 

### PEOPLE OF THE STATE OF MICHIGAN, Justices 

### Plaintiff-Appellee,

v SC: 132671 COA: 270244 Washtenaw CC: 97-009476-FC ARLANDUS M. NOLEN, Defendant-Appellant.

________________ _______________ __________/

On order of the Court, the application for leave to appeal the November 9, 2006 order of the Court of Appeals is considered, and it is DENIED, because the defendant has failed to meet the burden of establishi ng entitlement to relief under MCR 6.508(D).

d0618 I, Corbin R. Davis, Clerk of the Mi chigan Supreme Cour t, certify that the foregoing is a true and complete copy of the order entered at the direction of the Court.

June 26, 2007

Clerk
Editorial Note on Part 862
Editorial Note: Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.

§ 862.1550 Urinary pH (nonquantitative) test system. ( a ) *Identification.* A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.
( 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]
Editorial Note on Part 892
Editorial Note: Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.

§ 892.1110 Positron camera. ( a ) *Identification.* A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
( b ) *Classification.* Class I (general controls).
[55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]
Exhibit 35.10



LOGO

Annual Statement as to Compliance

For the Period of January 1, 2015 to December 31, 2015

GSMS 2015-GC32

In accordance with Item
1123 of Regulation AB andwith the Cypresswood Court Shopping Center Mortgage Loan requirements detailed in §10.07 of the Pooling and Servicing Agreement (the Agreement) for the above-mentioned CMBS pool, (the CMBS
Pool), CWCapital Asset Management LLC (CWCAM), in its capacity as Special Servicer, is providing this Officers Certificate with respect to the following:



| | (A) | a review of CWCAMs activities during the preceding calendar year or portion thereof (the Reporting Period) and of CWCAMs performance under the Agreement has been made under such officers
supervision and;
| | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | (B) | to the best of such officers knowledge, based on such review, CWCAM has fulfilled all its obligations under the Agreement in all material respects throughout the Reporting Period.
| | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Should you have any questions, please do not hesitate to contact us.

Sincerely,

CWCapital Asset Management LLC

David B. Iannarone

President

7501 Wisconsin Avenue, Suite 500 West, Bethesda, MD 20814

www.cwcapital.com
Editorial Note on Part 874
Editorial Note: Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.

§ 874.4140 Ear, nose, and throat bur. ( a ) *Identification.* An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.
( 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 § 874.9.
[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38800, July 25, 2001]
Editorial Note on Part 868
Editorial Note: Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.

§ 868.1975 Water vapor analyzer. ( a ) *Identification.* A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.
( 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.
[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001]
Editorial Note on Part 882
Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008.

§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder. ( a ) *Identification.* A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
( b ) *Classification.* Class II (special controls). The special controls for this device are: ( 1 ) The patient-contacting components of the device must be demonstrated to be biocompatible.
( 2 ) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
( 3 ) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed: ( i ) Electrical performance testing must validate electrical output and duration of stimulation;
( ii ) Battery performance testing must be performed; and
( iii ) Adhesive integrity testing of the electrodes must be conducted.
( 4 ) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized.
( 5 ) Software verification, validation, and hazard analysis must be performed.
( 6 ) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life.
( 7 ) Labeling must include the following: ( i ) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator;
( ii ) A warning that the device is only for use on clean, intact skin;
( iii ) Information on how the device operates and the typical sensations experienced during treatment;
( iv ) A detailed summary of the device technical parameters;
( v ) A shelf life for the electrodes;
( vi ) Instructions for use, including placement of the device on the patient; and
( vii ) Cleaning instructions.
[86 FR 70377, Dec. 10, 2021]
#### § 822.26 If my company changes ownership, what must I do?

You must notify us within 30 days of any change in ownership of your company. Your notification should identify any changes to the name or address of the company, the contact person, or the designated person (as defined in § 822.3(b)). Your obligation to conduct postmarket surveillance will generally transfer to the new owner, unless you and the new owner have both agreed that you will continue to conduct the surveillance. If you will continue to conduct the postmarket surveillance, you still must notify us of the change in ownership.
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**Title:****Flight procedures and airspace.
 
 
SuDoc Number:TD 4.8/2:8260.19 C
Item Number:431-C-04 (online)
CGP System Number:000570874
 
 
Basic Document Part 1
Basic Document Part 2
Change 1
Change 2
Change 3 Part 1
Change 3 Part 2
 
 
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August 30, 2017********
§ 884.2982 Liquid crystal thermographic system. ( a ) *A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for adjunctive use in diagnostic screening for detection of breast cancer or other uses* — ( 1 ) *Identification.* A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as an adjunct to physical palpation or mammography in diagnostic screening for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories.
( 2 ) *Classification.* Class I (general controls).
( b ) A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses— ( 1 ) *Identification.* A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as the sole diagnostic screening tool for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include image display and recording equipment, patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories.
( 2 ) *Classification.* Class III.
( 3 ) *Date PMA or notice of completion of a PDP is required.* As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.
[53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990; 66 FR 46953, Sept. 10, 2001]