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FDA 510(k) Application Details - K060082
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K060082
Device Name
Set, Administration, Intravascular
Applicant
TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.
WANSHUN GARDEN C 1801
89# HUANGPU NAN ROAD
HEXI DISTRICT, TIANJIN 300201 CN
Other 510(k) Applications for this Company
Contact
CINDY WANG
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2006
Decision Date
03/31/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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