ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES
FDA premarket approval P880082/S017 · decided 1994-10-04
Approval details
- PMA number
- P880082
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Eyetech, LLC
- Date received
- 1994-02-03
- Decision date
- 1994-10-04
- Days to decision
- 243 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Oakdale, MN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EPISCLERAL VENOUS PRESSURE (K843354) | Eyetech, LLC | 1984-11-19 |