ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
FDA premarket approval P820016/S002 · decided 1991-12-20
Approval details
- PMA number
- P820016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
- Generic name
- intraocular lens
- Applicant
- Cilco, Inc.
- Date received
- 1991-08-21
- Decision date
- 1991-12-20
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (K861334) | Cilco, Inc. | 1986-05-02 |
| CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) (K854969) | Cilco, Inc. | 1986-02-27 |
| K-SOL (K844249) | Cilco, Inc. | 1985-04-30 |
| CILCO I/A SURGICAL PACK (K843319) | Cilco, Inc. | 1985-02-14 |
| CILCOR OPHTHALMIC INSTRUMENTS (K843992) | Cilco, Inc. | 1984-11-21 |
| CILCO DIAMOND KNIFE (K843447) | Cilco, Inc. | 1984-10-05 |
| OCTOPUS 500/500E (K841099) | Cilco, Inc. | 1984-06-19 |
| CYSTOTOME, 140-S (K840475) | Cilco, Inc. | 1984-04-05 |