THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES
FDA premarket approval P880082/S009 · decided 1991-07-23
Approval details
- PMA number
- P880082
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Eyetech, LLC
- Date received
- 1990-11-21
- Decision date
- 1991-07-23
- Days to decision
- 244 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 |