§ 882.4030 — Skull Plate Anvil

(a) Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull.

(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 § 882.9.