21 C.F.R. § 868.5760 Cuff spreader.
Title 21 - Food and Drugs
(a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [47 FR 31142, July 16, 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
§ 868.5760 Cuff spreader.
