21 CFR 888.5960 - Cast removal instrument.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart E [§ 888.4150 - § 888.5980]

§ 888.5960 - Cast removal instrument.

(a) Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

(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.

[55 FR 48443, Nov. 20, 1990, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

cite as: 21 CFR 888.5960