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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 K943328
Device Name EVERYTHING KIDS
Applicant
Jcc Co., Inc.
330 Fifth Ave., Suite 200
New York,  NY  10001
Applicant Contact ALICE S MILLER
Correspondent
Jcc Co., Inc.
330 Fifth Ave., Suite 200
New York,  NY  10001
Correspondent Contact ALICE S MILLER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/12/1994
Decision Date 08/04/1994
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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