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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR882.4650]
See Related Information on Neurosurgical suture needle. 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. 882.4650 Neurosurgical suture needle.

(a)Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.

(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 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

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