Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
/ Subpart E - Surgical Devices / § 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.