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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 K873966
Device Name SUNGLASSES (NONPRESCRIPTION)
Applicant
Swank Plus , Ltd.
P.O. Box 70750
Kowloon Central Post Office
Hong Kong,  HK
Applicant Contact CIDER LAI
Correspondent
Swank Plus , Ltd.
P.O. Box 70750
Kowloon Central Post Office
Hong Kong,  HK
Correspondent Contact CIDER LAI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/29/1987
Decision Date 02/26/1988
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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