The following data is part of a premarket notification filed by Continental Soft Lens, Inc. with the FDA for Continental 45 (hefilcon A) Spherical & Aspheric Contact Lenses.
| Device ID | K943490 |
| 510k Number | K943490 |
| Device Name: | CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CONTINENTAL SOFT LENS, INC. 10 GLENVIEW DR. Littleton, CO 80123 |
| Contact | Wally Stirling |
| Correspondent | Wally Stirling CONTINENTAL SOFT LENS, INC. 10 GLENVIEW DR. Littleton, CO 80123 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-08-11 |