The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Alden Classic Tinted (polymacon) Soft (spherical & Toric) Daily Wear Contact Lens, Tinted (transparent/enhancing).
| Device ID | K980554 |
| 510k Number | K980554 |
| Device Name: | ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ALDEN OPTICAL LABS., INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin J Dalsing |
| Correspondent | Martin J 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 | 1998-02-13 |
| Decision Date | 1998-04-07 |
| Summary: | summary |