← Product Code [HMY](/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY) · K781412

# OSCILLATING KNIFE AND ACCESSORIES (K781412)

_Codman & Shurtleff, Inc. · HMY · Oct 11, 1978 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K781412

## Device Facts

- **Applicant:** Codman & Shurtleff, Inc.
- **Product Code:** [HMY](/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY.md)
- **Decision Date:** Oct 11, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4370
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K781412](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HMY/K781412)

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