← Product Code [HIT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT) · K903001

# SLIMCATH (TM) (K903001)

_Gynopharma, Inc. · HIT · Jun 25, 1991 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K903001

## Device Facts

- **Applicant:** Gynopharma, Inc.
- **Product Code:** [HIT](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT.md)
- **Decision Date:** Jun 25, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1170
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K903001](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIT/K903001)

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