← Product Code [KCZ](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ) · K921535

# SUOENA AFFINITY (TM) MODEL #802 (K921535)

_Coloplast Corp. · KCZ · May 11, 1992 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ/K921535

## Device Facts

- **Applicant:** Coloplast Corp.
- **Product Code:** [KCZ](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ.md)
- **Decision Date:** May 11, 1992
- **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/KCZ/K921535](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KCZ/K921535)

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