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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 K953782
Device Name NIL
Applicant
Dehang Industries, Ltd.
Flat 2, 4/Floor, Wah Chun Ind.
Bldg. 95 Chai Wan Kok St.
Tsuen Wan, N.T.,  HK
Applicant Contact PEDRO WONG
Correspondent
Dehang Industries, Ltd.
Flat 2, 4/Floor, Wah Chun Ind.
Bldg. 95 Chai Wan Kok St.
Tsuen Wan, N.T.,  HK
Correspondent Contact PEDRO WONG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/14/1995
Decision Date 09/12/1995
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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