§ 888.4150 - Calipers for clinical use.  


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  • § 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.

    [52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]