The following data is part of a premarket notification filed by Progressive Affiliated Labs, Inc. with the FDA for Lenses, Contact, Polymethyl Methacrylate.
Device ID | K760213 |
510k Number | K760213 |
Device Name: | LENSES, CONTACT, POLYMETHYL METHACRYLATE |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | PROGRESSIVE AFFILIATED LABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
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 | 1976-07-12 |
Decision Date | 1976-08-09 |