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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K110421
Device Name DISPOSABLE INSULIN SYRINGE
Applicant
Wenzhou Wuzhou Import & Export Co., Ltd.
P.O. Box 237-023
Bingyi Xiang, Zhejiang,  CN 325000
Applicant Contact Diana Hong
Correspondent
Wenzhou Wuzhou Import & Export Co., Ltd.
P.O. Box 237-023
Bingyi Xiang, Zhejiang,  CN 325000
Correspondent Contact Diana Hong
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/14/2011
Decision Date 04/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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