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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 K090012
Device Name DISPOSABLE INFUSION SET
Applicant
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
STE.8D, ZHONGXIN ZHONGSHAN
MANSION,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
MANSION,NO.19, LANE 999, ZHONG
SHAN NAN ER RD., SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/02/2009
Decision Date 06/11/2009
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
Recalls CDRH Recalls
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