← Product Code [NWA](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA) · K873742

# HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (K873742)

_Hood Laboratories · NWA · Oct 1, 1987 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K873742

## Device Facts

- **Applicant:** Hood Laboratories
- **Product Code:** [NWA](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA.md)
- **Decision Date:** Oct 1, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3720
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

## Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K873742](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NWA/K873742)

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