CUSTOM ARTIFICIAL HUMAN EYES
FDA 510(k) clearance K945270 · decided 1995-05-30
Clearance details
- K-number
- K945270
- Device name
- CUSTOM ARTIFICIAL HUMAN EYES
- Applicant
- Daniel T Acosta
- Decision
- Substantially Equivalent
- Date received
- 1994-10-28
- Decision date
- 1995-05-30
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- HQH
- Device class
- 1
- Regulation number
- 886.3200
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Diego, CA, 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 OCULAR PROSTHESIS (K946226) | Frank Tanaka, Ocularist, Inc. | 1995-03-22 |
| 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.