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FDA 510(k) Application Details - K060580
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K060580
Device Name
Set, Administration, Intravascular
Applicant
KAWASUMI LABORATORIES, INC.
4723 OAK FAIR BLVD
TAMPA, FL 33610 US
Other 510(k) Applications for this Company
Contact
JACK PAVLO
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
03/06/2006
Decision Date
06/06/2006
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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