The following data is part of a premarket notification filed by Flexlens, Inc. with the FDA for Flexlens 55 Soft (hydrophilic) Contact Lens.
| Device ID | K950294 |
| 510k Number | K950294 |
| Device Name: | FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | FLEXLENS, INC. 2890 SOUTH TEJON ST. Englewood, CO 80110 |
| Contact | David J Dougherty |
| Correspondent | David J Dougherty FLEXLENS, INC. 2890 SOUTH TEJON ST. Englewood, CO 80110 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1996-04-11 |