Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart E - Surgical Devices / § 888.5960 Cast removal instrument.
§ 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.