21 C.F.R. § 888.4200

Current through October 31, 2024
Section 888.4200 - Cement dispenser
(a)Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027 ) into surgical sites.
(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 .

21 C.F.R. §888.4200

52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815 , July 25, 2001