SORBIC ACID PRESERVED LENS LUBRICANT
FDA premarket approval P850075/S009 · decided 1997-07-02
Approval details
- PMA number
- P850075
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SORBIC ACID PRESERVED LENS LUBRICANT
- Generic name
- Accessories, soft lens products
- Applicant
- Paco Pharmaceutical Services, Inc.
- Date received
- 1997-05-01
- Decision date
- 1997-07-02
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Lakewood, NJ
- Statement
- APPROVAL FOR RELOCATION OF THE GRIFFITH MICROSCIENCE STERILIZATION SITE TO 27 PARK RD., GLEN FALLS, NY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CHARTER HARD CONTACT LENS CLEANING SOLUTION (K865111) | Paco Pharmaceutical Services, Inc. | 1987-01-20 |
| CHARTER LABORATORIES INC. LENS LUBRICANT (K863974) | Paco Pharmaceutical Services, Inc. | 1986-11-10 |
| CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (K862952) | Paco Pharmaceutical Services, Inc. | 1986-09-25 |
| STERILE SALINE SOLUTION (K843797) | Paco Pharmaceutical Services, Inc. | 1985-01-18 |
| STERILE WATER (K843796) | Paco Pharmaceutical Services, Inc. | 1984-12-10 |
| BANDAGE (K761093) | Paco Pharmaceutical Services, Inc. | 1977-01-06 |