Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart E - Surgical Devices / § 888.4210 Cement mixer for clinical use.
§ 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.