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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K171272
Device Name Cook-Swartz Doppler Flow Probe
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Tom Kardos
Correspondent
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Tom Kardos
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/01/2017
Decision Date 07/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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