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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shell, Scleral
510(k) Number K904961
Device Name ARTIFICIAL SCLERAL SHELL
Applicant
Midwest Eye Laboratories, Inc.
9975 Lyndale Ave. So.
Gettysburg Office Ctr. #550
Minneapolis,  MN  55420
Applicant Contact MICHAEL BARRETT
Correspondent
Midwest Eye Laboratories, Inc.
9975 Lyndale Ave. So.
Gettysburg Office Ctr. #550
Minneapolis,  MN  55420
Correspondent Contact MICHAEL BARRETT
Regulation Number886.3800
Classification Product Code
HQT  
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
Predetermined Change
Control Plan Authorized		 No
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