The following data is part of a premarket notification filed by Flexlens, Inc. with the FDA for Controlled Process Release Of Flexlens (hefilcon A).
| Device ID | K970312 |
| 510k Number | K970312 |
| Device Name: | CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | FLEXLENS, INC. 2890 SOUTH TEJON ST. Englewood, CO 80110 |
| Contact | Kevin M Randall |
| Correspondent | Kevin M Randall 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 | 1997-01-27 |
| Decision Date | 1997-04-02 |