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.