TC65B-SUV
FDA premarket approval P880072/S045 · decided 1997-03-13
Approval details
- PMA number
- P880072
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TC65B-SUV
- Generic name
- intraocular lens
- Applicant
- Eyekon Medical, Inc.
- Date received
- 1996-12-11
- Decision date
- 1997-03-13
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Clearwater, FL
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT TRI-STATE, HOSPITAL SUPPLY CORP., 3310 S. MAIN ST., SALISBURY, N.C. 28147
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |