Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart E - Surgical Devices / § 888.4300 Depth gauge for clinical use.
§ 888.4300 Depth gauge for clinical use.
(a) Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.
(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.