§ 882.4500. Cranioplasty material forming instrument.
73 words·~1 min read·
/us/cfr/t21/s§ 882.4500·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials.
(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. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]