EYE ARTIFICIAL CUSTOM

Eye, Artificial, Non-custom

MIDWEST EYE LABORATORIES, INC.

The following data is part of a premarket notification filed by Midwest Eye Laboratories, Inc. with the FDA for Eye Artificial Custom.

Pre-market Notification Details

Device IDK904962
510k NumberK904962
Device Name:EYE ARTIFICIAL CUSTOM
ClassificationEye, Artificial, Non-custom
Applicant MIDWEST EYE LABORATORIES, INC. 9975 LYNDALE AVENUE SO. GETTYSBURG OFFICE CTR. #550 Minneapolis,  MN  55420
ContactMichael Barrett
CorrespondentMichael Barrett
MIDWEST EYE LABORATORIES, INC. 9975 LYNDALE AVENUE SO. GETTYSBURG OFFICE CTR. #550 Minneapolis,  MN  55420
Product CodeHQH  
CFR Regulation Number886.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-05
Decision Date1991-08-30

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