The following data is part of a premarket notification filed by Alden Optical Labs., Inc. with the FDA for Al-47 (polymacon) Soft (spherical & Toric) Daily Wear Contact Lens (clear & Tinted, Lathe-cut From Lens Blank).
| Device ID | K973967 |
| 510k Number | K973967 |
| Device Name: | AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) |
| 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 | 1997-10-17 |
| Decision Date | 1997-12-08 |
| Summary: | summary |