Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart E - Surgical Devices / § 888.4150 Calipers for clinical use.
§ 888.4150 Calipers for clinical use.
(a) Identification. A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.
(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.