← Product Code [HPC](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC) · K770389

# LENS SET, MENTOR TRIAL (K770389)

_Codman & Shurtleff, Inc. · HPC · Mar 14, 1977 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K770389

## Device Facts

- **Applicant:** Codman & Shurtleff, Inc.
- **Product Code:** [HPC](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC.md)
- **Decision Date:** Mar 14, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1405
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K770389](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPC/K770389)

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