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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 K900521
Device Name MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER
Applicant
J & B Assoc.
P.O. Box 540713
Dallas,  TX  75220
Applicant Contact BILL WILSON
Correspondent
J & B Assoc.
P.O. Box 540713
Dallas,  TX  75220
Correspondent Contact BILL WILSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/02/1990
Decision Date 05/03/1990
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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