NOVALENS (ROSILFOCON A)
FDA premarket approval P890058/S012 · decided 1994-01-04
Approval details
- PMA number
- P890058
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVALENS (ROSILFOCON A)
- Generic name
- Lens, contact (other material) - daily
- Applicant
- Ocutec Corporation, Inc.
- Date received
- 1993-04-07
- Decision date
- 1994-01-04
- Days to decision
- 272 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Morrisville, NC
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NOVALENS/NOVAWET PERCEPTION AND VANGUARD (K942533) | Ocutec Corporation, Inc. | 1994-08-05 |