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 874 - EAR, NOSE, AND THROAT DEVICES
/ Subpart E - Surgical Devices / § 874.4800 Bone particle collector.
§ 874.4800 Bone particle collector.
(a) Identification. A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.