The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Alden Classic (polymacon) Multifocal (spherical And Toric), Alden Classic 55 (methafilcon A) Multifocal (spherical.
| Device ID | K052703 |
| 510k Number | K052703 |
| Device Name: | ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 13295 BROADWAY Alden, NY 14004 |
| Contact | Charles H Creighton |
| Correspondent | Charles H Creighton ALDEN OPTICAL LABS., INC. 13295 BROADWAY Alden, NY 14004 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-11-10 |