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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 K941119
Device Name XIAMEN DYNASTY OPTICAL CORP
Applicant
Xiamen Dynasty Optical Corp. , Ltd.
Huli Industrial District
Huli Rd.
Xiamen Fujian Province,  CN 361006
Applicant Contact HUANG D SAN
Correspondent
Xiamen Dynasty Optical Corp. , Ltd.
Huli Industrial District
Huli Rd.
Xiamen Fujian Province,  CN 361006
Correspondent Contact HUANG D SAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/07/1994
Decision Date 06/06/1994
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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