The following data is part of a premarket notification filed by Applied Laboratories, Inc. with the FDA for Easy Eyes Tm Lens Carrying Case.
Device ID | K853870 |
510k Number | K853870 |
Device Name: | EASY EYES TM LENS CARRYING CASE |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus, IN 47201 |
Contact | Anthony J Moravec |
Correspondent | Anthony J Moravec APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus, IN 47201 |
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 | 1985-09-17 |
Decision Date | 1985-12-10 |