← Product Code [GBI](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBI) · K874279

# AHH NATURAL BREAST FORM (K874279)

_Pacific Prosthetics, Inc. · GBI · Oct 29, 1987 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBI/K874279

## Device Facts

- **Applicant:** Pacific Prosthetics, Inc.
- **Product Code:** [GBI](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBI.md)
- **Decision Date:** Oct 29, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3800
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBI/K874279](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBI/K874279)

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