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FDA 510(k) Application Details - K090459
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K090459
Device Name
Set, Administration, Intravascular
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 200030 CN
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Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2009
Decision Date
10/13/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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