← Product Code [HQD](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD) · K963512

# BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL (K963512)

_Benz Research and Development Corp. · HQD · Jul 31, 1997 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K963512

## Device Facts

- **Applicant:** Benz Research and Development Corp.
- **Product Code:** [HQD](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD.md)
- **Decision Date:** Jul 31, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5916
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K963512](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K963512)

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