CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS
FDA premarket approval P800017/S003 · decided 1987-09-21
Approval details
- PMA number
- P800017
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Storz Ophthalmics, Inc.
- Date received
- 1987-03-16
- Decision date
- 1987-09-21
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599) | Storz Ophthalmics, Inc. | 1995-03-02 |
| MEDITEC QL-15 ND:YAG LASER (K884060) | Storz Ophthalmics, Inc. | 1988-11-04 |