ALLERGAN(R) REWETTING DROPS
FDA premarket approval P910075/S006 · decided 1996-02-23
Approval details
- PMA number
- P910075
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALLERGAN(R) REWETTING DROPS
- Generic name
- Accessories, soft lens products
- Applicant
- Advanced Medical Optics, Inc.
- Date received
- 1995-06-08
- Decision date
- 1996-02-23
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITRECTOMY CUTTER AND ACCESSORIES (K081681) | Advanced Medical Optics, Inc. | 2008-10-08 |
| ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545) | Advanced Medical Optics, Inc. | 2008-10-02 |
| THE AMO OPHTHALMIC SURGICAL SYSTEM (K060366) | Advanced Medical Optics, Inc. | 2006-04-07 |
| LENS PLUS REWETTING DROPS (K042562) | Advanced Medical Optics, Inc. | 2005-07-29 |
| SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK (K050648) | Advanced Medical Optics, Inc. | 2005-04-05 |
| COMPLETE BLINK-N-CLEAN LENS DROPS (K040839) | Advanced Medical Optics, Inc. | 2004-10-19 |
| BLINK CL LUBRICANT EYE DROPS (K032030) | Advanced Medical Optics, Inc. | 2003-09-25 |
| COMPLETE BRAND MULTI-PURPOSE SOLUTION (K030092) | Advanced Medical Optics, Inc. | 2003-04-04 |