Cement monomer vapor evacuator.

21 C.F.R. § 888.4220
in effectEffective: 2024-07-01
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(a) 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). (b) 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.

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