The following data is part of a premarket notification filed by Poly Vue Technolgies, Inc. with the FDA for Hd/hdt, Pv/pvt (polymacon) Soft Contact Lens For Daily Wear (clear And Tinted, Fully Cast-molded Lens).
| Device ID | K013220 |
| 510k Number | K013220 |
| Device Name: | HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | POLY VUE TECHNOLGIES, INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing POLY VUE TECHNOLGIES, INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-26 |
| Decision Date | 2001-11-20 |
| Summary: | summary |