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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angiographic Coronary Vascular Physiologic Simulation Software
510(k) Number K192442
Device Name FFRangio
Applicant
CathWorks Ltd
3 Rapaport Street
Kfar-Saba,  IL 4465141
Applicant Contact Asaf Azulay
Correspondent
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.1415
Classification Product Code
QEK  
Date Received09/06/2019
Decision Date 12/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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