The following data is part of a premarket notification filed by Kontur Kontact Lens Co., Inc. with the FDA for Kontur 55 Soft Lens.
| Device ID | K001908 |
| 510k Number | K001908 |
| Device Name: | KONTUR 55 SOFT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | KONTUR KONTACT LENS CO., INC. P.O. BOX 253 Lafayette, CO 80026 |
| Contact | Kevin M Randall |
| Correspondent | Kevin M Randall KONTUR KONTACT LENS CO., INC. P.O. BOX 253 Lafayette, CO 80026 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-22 |
| Decision Date | 2000-08-18 |