← Product Code [JXS](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS) · K950308

# STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (K950308)

_Solarcare Technologies Corp,Inc. · JXS · Apr 14, 1995 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94prosthetic-devices/JXS/K950308

## Device Facts

- **Applicant:** Solarcare Technologies Corp,Inc.
- **Product Code:** [JXS](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JXS.md)
- **Decision Date:** Apr 14, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3540
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTM punch; wire cutting scissors; and ossicular finger vise.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94prosthetic-devices/JXS/K950308](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94prosthetic-devices/JXS/K950308)

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