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FDA 510(k) Application Details - K103260
Device Classification Name
Catheter, Ultrasound, Intravascular
More FDA Info for this Device
510(K) Number
K103260
Device Name
Catheter, Ultrasound, Intravascular
Applicant
VASONOVA INC.
155 JEFFERSON DRIVE
SUITE 100
MENLO PARK, CA 94025 US
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Contact
KIM TOMPKINS
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
OBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/04/2010
Decision Date
02/18/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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