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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K963284
Device Name RAVEN EYE- EYE WEAR (SUNGLASSES)
Applicant
Raven Eye, Inc.
3333 Earhart, Suite 200
Carrollton,  TX  75006
Applicant Contact ROBERT COOK
Correspondent
Raven Eye, Inc.
3333 Earhart, Suite 200
Carrollton,  TX  75006
Correspondent Contact ROBERT COOK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/29/1996
Decision Date 08/26/1996
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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