§888.4300. Depth gauge for clinical use.
21 C.F.R. § 888.4300
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.
Amendments
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]