The following data is part of a premarket notification filed by Paco Pharmaceutical Services, Inc. with the FDA for Charter Hard Contact Lens Cleaning Solution.
| Device ID | K865111 |
| 510k Number | K865111 |
| Device Name: | CHARTER HARD CONTACT LENS CLEANING SOLUTION |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | PACO PHARMACEUTICAL SERVICES, INC. 1200 PACO WAY BUILDING 19 Lakewood, NJ 08701 |
| Contact | Joanne B Marriott |
| Correspondent | Joanne B Marriott PACO PHARMACEUTICAL SERVICES, INC. 1200 PACO WAY BUILDING 19 Lakewood, NJ 08701 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-31 |
| Decision Date | 1987-01-20 |