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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name eye, artificial, non-custom
510(k) Number K904962
Device Name EYE ARTIFICIAL CUSTOM
Applicant
MIDWEST EYE LABORATORIES, INC.
9975 LYNDALE AVENUE SO.
GETTYSBURG OFFICE CTR. #550
MINNEAPOLIS,  MN  55420
Applicant Contact MICHAEL BARRETT
Correspondent
MIDWEST EYE LABORATORIES, INC.
9975 LYNDALE AVENUE SO.
GETTYSBURG OFFICE CTR. #550
MINNEAPOLIS,  MN  55420
Correspondent Contact MICHAEL BARRETT
Regulation Number886.3200
Classification Product Code
HQH  
Date Received11/05/1990
Decision Date 08/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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