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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 K941296
Device Name SUNGLASSES
Applicant
Three Leaves Industrial Co., Ltd.
P.O. Box 36-827
Taipei, Taiwan, R.O.C.,  CN
Applicant Contact JACK WHITE
Correspondent
Three Leaves Industrial Co., Ltd.
P.O. Box 36-827
Taipei, Taiwan, R.O.C.,  CN
Correspondent Contact JACK WHITE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/17/1994
Decision Date 06/03/1994
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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