Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3925](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3925) → FTN — Plastic Surgery And Accessories Kit

# FTN · Plastic Surgery And Accessories Kit

_General, Plastic Surgery · 21 CFR 878.3925 · Class 1_

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

## Overview

- **Product Code:** FTN
- **Device Name:** Plastic Surgery And Accessories Kit
- **Regulation:** [21 CFR 878.3925](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3925)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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