← Product Code [HQH](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH) · K952538

# ROBERT B. SCOTT PLASTIC ARTIFICAL (K952538)

_Robert B. Scott Ocularists of Florida, Inc. · HQH · Jun 26, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538

## Device Facts

- **Applicant:** Robert B. Scott Ocularists of Florida, Inc.
- **Product Code:** [HQH](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH.md)
- **Decision Date:** Jun 26, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3200
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538)

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