Title 21

SECTION 876.4560

876.4560 Ribdam.

§ 876.4560 Ribdam.

(a) Identification. A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.

(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 § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, 2001]

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