21 Food and Drugs 8 2003-04-01 2003-04-01 false Neurosurgical headrests. 882.4440 Section 882.4440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices
§ 882.4440 Neurosurgical headrests.

(a) Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.

(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 § 882.9.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]