CHARTER LABS SALINE SOLUTION
FDA premarket approval P840069/S007 · decided 1997-07-02
Approval details
- PMA number
- P840069
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CHARTER LABS SALINE SOLUTION
- 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.
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 |
|---|---|---|
| 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 |