← Product Code [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB) · K001142

# AUDIO TECHNOLOGIES S:R.1 (K001142)

_Audio Technologies S.R.L. · ETB · Jun 23, 2000 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K001142

## Device Facts

- **Applicant:** Audio Technologies S.R.L.
- **Product Code:** [ETB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB.md)
- **Decision Date:** Jun 23, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3450
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K001142](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETB/K001142)

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