← Product Code [HPX](/productcode/HPX) · K770582

# LENS, CONTACT, HARD (K770582)

_Berea Contact Lens, Inc. · HPX · May 6, 1977 · OP · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K770582

## Device Facts

- **Applicant:** Berea Contact Lens, Inc.
- **Product Code:** [HPX](/productcode/HPX.md)
- **Decision Date:** May 6, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** OP

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**Source:** [https://fda-staging.innolitics.com/device/K770582](https://fda-staging.innolitics.com/device/K770582)

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