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FDA 510(k) Application Details - K023668
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K023668
Device Name
Set, Administration, Intravascular
Applicant
JMS NORTH AMERICA CORP.
22320 FOOTHILL BLVD.,
SUITE 350
HAYWARD, CA 94541 US
Other 510(k) Applications for this Company
Contact
SWEE CHEAU CHONG
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
10/31/2002
Decision Date
07/01/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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