§888.4220. Cement monomer vapor evacuator.
21 C.F.R. § 888.4220
Identification. A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (§ 888.3027).
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Notes, amendments, and revision history
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 66 FR 38815, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 66 FR 38815, July 25, 2001]