The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Rigid Gas Permeable Contact Lens Solution.
| Device ID | K011945 |
| 510k Number | K011945 |
| Device Name: | RIGID GAS PERMEABLE CONTACT LENS SOLUTION |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Contact | Debra L.b. Ketchum |
| Correspondent | Debra L.b. Ketchum POLYMER TECHNOLOGY CORP. 1400 N. GOODMAN ST. Rochester, NY 14692 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-21 |
| Decision Date | 2001-09-12 |
| Summary: | summary |