The following data is part of a premarket notification filed by Polymer Technology Div. Wilmington Partners, L.p. with the FDA for Rigid Gas Permeable Contact Lens Solution.
| Device ID | K983836 |
| 510k Number | K983836 |
| Device Name: | RIGID GAS PERMEABLE CONTACT LENS SOLUTION |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. 1400 NORTH GOODMAN ST. Rochester, NY 14692 |
| Contact | Debra L.b. Ketchum |
| Correspondent | Debra L.b. Ketchum POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. 1400 NORTH GOODMAN ST. Rochester, NY 14692 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-02-11 |
| Summary: | summary |