The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Contaflex 38 (polymacon) Spherical Soft Contact Lens For Daily Wear (clear And Tinted, Lathe-cut).
| Device ID | K023987 |
| 510k Number | K023987 |
| Device Name: | CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CONTAMAC LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CONTAMAC LTD. 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 | 2002-12-02 |
| Decision Date | 2003-02-26 |
| Summary: | summary |