§874.4800. Bone particle collector.
21 C.F.R. § 874.4800
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.
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.
Notes, amendments, and revision history
Amendments
[64 FR 10949, Mar. 8, 1999]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[64 FR 10949, Mar. 8, 1999]