SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
FDA premarket approval P870007/S009 · decided 1995-09-20
Approval details
- PMA number
- P870007
- Supplement
- S009
- 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
- 1995-08-08
- Decision date
- 1995-09-20
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairton, NJ
- Statement
- APPROVAL FOR MODIFICATION OF THE STABILITY SPECIFICATIONS FOR SORBIC ACID CONCENTRATION FROM A RANGE OF 0.80 MG/ML - 1.20 MG/ML TO 0.70 MG/ML - 1.20 MG/ML
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| WETTING SOLUTION FOR HARD CONTACT LENSES (K914483) | Optopics Laboratories Corp. | 1992-02-05 |