← Product Code [FZE](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE) · K863430

# BYRON BIVALVE NASAL SPLINTS (K863430)

_Byron Medical · FZE · Sep 17, 1986 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K863430

## Device Facts

- **Applicant:** Byron Medical
- **Product Code:** [FZE](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE.md)
- **Decision Date:** Sep 17, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3680
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K863430](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K863430)

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