21 CFR 878.3925 — Plastic Surgery And Accessories Kit

General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3925

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
FTNPlastic Surgery And Accessories Kit10
Innolitics

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