SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
FDA premarket approval P870007/S006 · decided 1993-04-14
Approval details
- PMA number
- P870007
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
- Generic name
- Accessories, soft lens products
- Applicant
- Optopics Laboratories Corp.
- Date received
- 1992-05-12
- Decision date
- 1993-04-14
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairton, NJ
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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 |