BLAIREX STERILE SALINE SOLUTION
FDA premarket approval P850045/S015 · decided 1994-05-27
Approval details
- PMA number
- P850045
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BLAIREX STERILE SALINE SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Blairex Laboratories, Inc.
- Date received
- 1992-09-24
- Decision date
- 1994-05-27
- Days to decision
- 610 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Columbus, IN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 (K083355) | Blairex Laboratories, Inc. | 2008-12-29 |
| BENZETHONIUM CHLORIDE (K833903) | Blairex Laboratories, Inc. | 1984-05-30 |
| HARD CONTACT LENS CLEANER (K832810) | Blairex Laboratories, Inc. | 1983-09-29 |