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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 K873983
Device Name CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021
Applicant
Arcotoys, Inc.
800 Shames Dr.
C.S. 1015
Westbury,  NY  11590
Applicant Contact WILLIAM J QUINLAN
Correspondent
Arcotoys, Inc.
800 Shames Dr.
C.S. 1015
Westbury,  NY  11590
Correspondent Contact WILLIAM J QUINLAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/30/1987
Decision Date 12/02/1987
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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