← Product Code [ETC](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETC) · K921433

# ATTIC DEFECT PLATE (K921433)

_Smith & Nephew Richards, Inc. · ETC · Mar 18, 1993 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETC/K921433

## Device Facts

- **Applicant:** Smith & Nephew Richards, Inc.
- **Product Code:** [ETC](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETC.md)
- **Decision Date:** Mar 18, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3430
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETC/K921433](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETC/K921433)

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