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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR888.4300]
 See Related Information on 888.4300 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 888 -- ORTHOPEDIC DEVICES

Subpart E--Surgical Devices

Sec. 888.4300 Depth gauge for clinical use.

(a)Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

(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 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

 
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