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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 K843961
Device Name COLOR OPTIC CORNEAL EYE SHIELD
Applicant
Colors IN Optics , Ltd.
18 Stoneleigh Close
Scarsdale,  NY  10583
Applicant Contact ANDREW P BRUCKER
Correspondent
Colors IN Optics , Ltd.
18 Stoneleigh Close
Scarsdale,  NY  10583
Correspondent Contact ANDREW P BRUCKER
Regulation Number886.4750
Classification Product Code
HOY  
Date Received10/11/1984
Decision Date 11/28/1984
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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