21 C.F.R. § 888.4200 Cement dispenser.
Title 21 - Food and Drugs
(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. [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]
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart E—Surgical Devices
§ 888.4200 Cement dispenser.
