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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 K881135
Device Name COOL EYE(TM) EYE PROTECTOR
Applicant
Cool Eyes, Inc.
P.O. Box 1244
Harrow, Ontario,  CA NOR 1GO
Applicant Contact ANNE MILLER
Correspondent
Cool Eyes, Inc.
P.O. Box 1244
Harrow, Ontario,  CA NOR 1GO
Correspondent Contact ANNE MILLER
Regulation Number886.4750
Classification Product Code
HOY  
Date Received03/16/1988
Decision Date 07/08/1988
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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