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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 K943443
Device Name SUNGLASSES
Applicant
Sunny Union Industrial Co., Ltd.
P.O. Box 53-1105, 4f, # 39
Ln. 131 Yen - Chi St.
Taipei,  TW
Applicant Contact TEDDY WANG
Correspondent
Sunny Union Industrial Co., Ltd.
P.O. Box 53-1105, 4f, # 39
Ln. 131 Yen - Chi St.
Taipei,  TW
Correspondent Contact TEDDY WANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/18/1994
Decision Date 08/02/1994
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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