21 C.F.R. § 868.5560 Gas mask head strap.
Title 21 - Food and Drugs
(a) Identification. A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face. (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 §868.9. [47 FR 41107, Sept. 17, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5560 Gas mask head strap.