(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 requirements of the quality system regulation 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]