CUSTOM OCULAR PROSTHESIS
FDA 510(k) clearance K946226 · decided 1995-03-22
Clearance details
- K-number
- K946226
- Device name
- CUSTOM OCULAR PROSTHESIS
- Applicant
- Frank Tanaka, Ocularist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-22
- Decision date
- 1995-03-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HQH
- Device class
- 1
- Regulation number
- 886.3200
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ROBERT B. SCOTT PLASTIC ARTIFICAL (K952538) | Robert B. Scott Ocularists of Florida, Inc. | 1995-06-26 |
| CUSTOM ARTIFICIAL HUMAN EYES (K945270) | Daniel T Acosta | 1995-05-30 |
| THE NISSEL ARTIFICIAL EYE (K923167) | Nissel , Ltd. | 1992-09-02 |
| EYE ARTIFICIAL CUSTOM (K904962) | Midwest Eye Laboratories, Inc. | 1991-08-30 |
| SCLERAL POWDER (K791923) | Ocularists , Ltd. | 1980-01-10 |
Recalls involving this device
No recalls on record reference this clearance.