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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR882.4300]
 See Related Information on Manual cranial drills, burrs, trephines, and their accessories 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 882 -- NEUROLOGICAL DEVICES

Subpart E - Neurological Surgical Devices

Sec. 882.4300 Manual cranial drills, burrs, trephines, and their accessories

(a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

(b) Classification. Class II (performance standards).

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