21 CFR 888.4220 — Evacuator, Vapor, Cement Monomer

Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 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 Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JDYEvacuator, Vapor, Cement Monomer18
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