§ 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.