CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 874—EAR, NOSE, AND THROAT DEVICES > SUBPART E—Surgical Devices (§874.4100 to §874.4800) > 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.

Code of Federal Regulations

[64 FR 10949, Mar. 8, 1999]