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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 K853921
Device Name ALL KINDS OF SUNGLASSES
Applicant
Winsburn Company , Ltd.
6f-2, 4 Ching Tao E. Rd.
Taipei, Taiwan
Republic Of China,  TW
Applicant Contact GRABOWSKY
Correspondent
Winsburn Company , Ltd.
6f-2, 4 Ching Tao E. Rd.
Taipei, Taiwan
Republic Of China,  TW
Correspondent Contact GRABOWSKY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/23/1985
Decision Date 10/15/1985
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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