The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Visalens All Purpose Solution For Lens.
Device ID | K791523 |
510k Number | K791523 |
Device Name: | VISALENS ALL PURPOSE SOLUTION FOR LENS |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | PFIZER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HPX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-10 |
Decision Date | 1980-02-19 |