21 CFR 878.3925
§ 878.3925 Plastic surgery kit and accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.3925, § 878.3925 Plastic surgery kit and accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90401
- Permanent ID
ys:prov:90401@1- SHA-256
5b9b04a306d11103c79dc193c3d9d32e787f06836e7d9af35935f4878e423ed5
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Full text
(a) Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external 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 § 878.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.