The following data is part of a premarket notification filed by Optikem Polymers, Inc. with the FDA for Optikem Pmma Contact Lens.
| Device ID | K895411 |
| 510k Number | K895411 |
| Device Name: | OPTIKEM PMMA CONTACT LENS |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | OPTIKEM POLYMERS, INC. 2890 SOUTH TEJON ST. Englewood, CO 80110 |
| Contact | William Hoffman |
| Correspondent | William Hoffman OPTIKEM POLYMERS, INC. 2890 SOUTH TEJON ST. Englewood, CO 80110 |
| 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 | 1989-09-06 |
| Decision Date | 1990-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858174006003 | K895411 | 000 |