HQH — Eye, Artificial, Non-Custom Class I
FDA product code HQH covers "Eye, Artificial, Non-Custom", a Class I medical device regulated under 21 CFR 886.3200. Submissions are reviewed by the Ophthalmic panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQH
- Device Class
- Class I
- Regulation Number
- 886.3200
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952538 | robert b. scott ocularists of florida | ROBERT B. SCOTT PLASTIC ARTIFICAL | June 26, 1995 |
| K945270 | daniel t acosta | CUSTOM ARTIFICIAL HUMAN EYES | May 30, 1995 |
| K946226 | frank tanaka, ocularist | CUSTOM OCULAR PROSTHESIS | March 22, 1995 |
| K923167 | nissel | THE NISSEL ARTIFICIAL EYE | September 2, 1992 |
| K904962 | midwest eye laboratories | EYE ARTIFICIAL CUSTOM | August 30, 1991 |
| K791923 | ocularists | SCLERAL POWDER | January 10, 1980 |