21 C.F.R. § 874.4800
Bone particle collector.
Cite as 21 C.F.R. § 874.4800 (2026)
(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.
[64 FR 10949, Mar. 8, 1999]
- Cross-references to the CFR
- 874.9.