SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
FDA premarket approval P870007/S010 · decided 1996-04-22
Approval details
- PMA number
- P870007
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
- Generic name
- Accessories, soft lens products
- Applicant
- Optopics Laboratories Corp.
- Date received
- 1995-10-03
- Decision date
- 1996-04-22
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairton, NJ
- Statement
- APPROVAL FOR TRANSFER OF THE PROCESSING SITE FOR 100 PERCENT ETHYLENE OXIDE (ETO) STERILIZATION OF PLASTIC CONTAINERS, TIPS AND CLOSURES USED IN THE MANUFACTURE OF SORBIC ACID PRESERVED STERILE SALINE FOR SOFT CONTACT LENSES. THE ETO STERILIZATION FACILITY IS GRIFFITH MICROSCIENCE GLEN FALLS FACILITY, LOCATED IN GLEN FALLS, NY
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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 |