SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
FDA premarket approval P870007/S011 · decided 1996-11-13
Approval details
- PMA number
- P870007
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
- Generic name
- Accessories, soft lens products
- Applicant
- Optopics Laboratories Corp.
- Date received
- 1996-05-20
- Decision date
- 1996-11-13
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairton, NJ
- Statement
- APPROVAL TO MARKET THE DEVICE IN A 16 FL. OZ. CONTAINER SIZE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| WETTING SOLUTION FOR HARD CONTACT LENSES (K914483) | Optopics Laboratories Corp. | 1992-02-05 |