 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 888 - Orthopedic Devices |
|
Subpart E - Surgical Devices |
§ 888.4200 - Cement dispenser.
Latest version.
-
§ 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.
[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]