The following data is part of a premarket notification filed by Flexlens, Inc. with the FDA for Flexlens(methafilcon A).
| Device ID | K962000 |
| 510k Number | K962000 |
| Device Name: | FLEXLENS(METHAFILCON A) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | FLEXLENS, INC. S. EAST REGULATORY ASSO., INC. 235 NORTH TALBOT COURT Roswell, GA 30076 -2480 |
| Contact | Wally Stirling |
| Correspondent | Wally Stirling FLEXLENS, INC. S. EAST REGULATORY ASSO., INC. 235 NORTH TALBOT COURT Roswell, GA 30076 -2480 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-22 |
| Decision Date | 1996-10-01 |
| Summary: | summary |