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FDA 510(k) Application Details - K083429
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K083429
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
STE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI 200030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2008
Decision Date
08/07/2009
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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