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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K090459
Device Name DISPOSABLE TPE INFUSION SET
Applicant
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
STE.8D, ZHONGXIN ZHONGSHAN #2
ROADY ,NO.19, LANE 999, ZHONG
SHAN NAN ER RD., SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
STE.8D, ZHONGXIN ZHONGSHAN #2
ROADY ,NO.19, LANE 999, ZHONG
SHAN NAN ER RD., SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/23/2009
Decision Date 10/13/2009
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
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