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Title 21 → Chapter I → Subchapter H → Part 888 → Subpart E → §888.4210 |
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart E—Surgical Devices
§888.4210 Cement mixer for clinical use.
(a) Identification. A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (§888.3027).
(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]