Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart E - Surgical Devices / § 888.4220 Cement monomer vapor evacuator.
§ 888.4220 Cement monomer vapor evacuator.
(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.