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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K896171
Device Name EYE PATCH
Applicant
Eye Garter Company, Inc.
8535 W. Bellfort
Houston,  TX  77071
Applicant Contact GOFFMAN, MD
Correspondent
Eye Garter Company, Inc.
8535 W. Bellfort
Houston,  TX  77071
Correspondent Contact GOFFMAN, MD
Regulation Number886.4750
Classification Product Code
HOY  
Date Received10/25/1989
Decision Date 11/03/1989
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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