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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 K971551
Device Name DUQIAO
Applicant
Duqiao Glasses (Group) Co. , Ltd.
279 Fuqian St., Duqiao
Linhai, Zhejiang,  CN
Applicant Contact MERRY CHEN
Correspondent
Duqiao Glasses (Group) Co. , Ltd.
279 Fuqian St., Duqiao
Linhai, Zhejiang,  CN
Correspondent Contact MERRY CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/28/1997
Decision Date 06/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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