The following data is part of a premarket notification filed by Polymer Technology with the FDA for Rigid Gas Permeable Contact Lens.
| Device ID | K000795 |
| 510k Number | K000795 |
| Device Name: | RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | POLYMER TECHNOLOGY 1400 N GOODMAN ST. Rochester, NY 14692 |
| Contact | Debra L.b. Ketchum |
| Correspondent | Debra L.b. Ketchum POLYMER TECHNOLOGY 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 | 2000-03-13 |
| Decision Date | 2000-05-26 |
| Summary: | summary |