View all text of Subpart E [§ 888.4150 - § 888.5980]
§ 888.4210 - Cement mixer for clinical use.
(a) Identification. A cement mixer for clinical use is a device consisting of a container intended for use in mixing 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.