← Product Code [FZD](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD) · K863939

# POREX(TM) EAR PROSTHESIS (K863939)

_Porex Medical · FZD · Oct 24, 1986 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K863939

## Device Facts

- **Applicant:** Porex Medical
- **Product Code:** [FZD](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD.md)
- **Decision Date:** Oct 24, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3590
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K863939](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZD/K863939)

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