(a)Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.
(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]