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FDA 510(k) Application Details - K153090
Device Classification Name
More FDA Info for this Device
510(K) Number
K153090
Device Name
Reprocessed Diagnostic Ultrasound Catheter
Applicant
INNOVATIVE HEALTH, LLC
1435 NORTH HAYDEN ROAD, SUITE 100
SCOTTSDALE, AZ 85257 US
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Contact
RAFAL CHUDZIK
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/26/2015
Decision Date
03/10/2016
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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