The following data is part of a premarket notification filed by Eaton Medical Corp. with the FDA for Easy Eyes Tm Lens Carrying Case.
Device ID | K841881 |
510k Number | K841881 |
Device Name: | EASY EYES TM LENS CARRYING CASE |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | EATON MEDICAL CORP. 2288 CENTRAL Memphis , TN 38104 - |
Contact | Anthony J Moravec |
Correspondent | Anthony J Moravec EATON MEDICAL CORP. 2288 CENTRAL Memphis , TN 38104 - |
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 | 1984-05-07 |
Decision Date | 1984-12-03 |