The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Alden Classic Prosthetic (polymacon) Tinted, Soft Daily Wear Contact Lens (sighted And Non-sighted Eyes).
| Device ID | K983053 |
| 510k Number | K983053 |
| Device Name: | ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing ALDEN OPTICAL LABS., INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-01 |
| Decision Date | 1998-10-21 |
| Summary: | summary |