The following data is part of a premarket notification filed by Midwest Eye Laboratories, Inc. with the FDA for Eye Artificial Custom.
Device ID | K904962 |
510k Number | K904962 |
Device Name: | EYE ARTIFICIAL CUSTOM |
Classification | Eye, Artificial, Non-custom |
Applicant | MIDWEST EYE LABORATORIES, INC. 9975 LYNDALE AVENUE SO. GETTYSBURG OFFICE CTR. #550 Minneapolis, MN 55420 |
Contact | Michael Barrett |
Correspondent | Michael Barrett MIDWEST EYE LABORATORIES, INC. 9975 LYNDALE AVENUE SO. GETTYSBURG OFFICE CTR. #550 Minneapolis, MN 55420 |
Product Code | HQH |
CFR Regulation Number | 886.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-05 |
Decision Date | 1991-08-30 |