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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 K932838
Device Name SUNGLASSES AND OPTICAL FRAMES, CARBON AND METAL FRAMES
Applicant
Wonderful Optical Co., Ltd.
P.O. Box 34-50
Taipei,  TW
Applicant Contact DAVID CHAO
Correspondent
Wonderful Optical Co., Ltd.
P.O. Box 34-50
Taipei,  TW
Correspondent Contact DAVID CHAO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/11/1993
Decision Date 10/06/1993
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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