21 CFR 878.3750 — Prosthesis, Adhesive, External

General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3750

Identification

An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.

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 the limitations in § 878.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
GBJProsthesis, Adhesive, External14
Innolitics

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