§ 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.