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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K170204
Device Name FFR Link, FFR Signal Processing Module
Applicant
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Applicant Contact Dan Krause
Correspondent
Boston Scientific Corporation
47215 Lakeview Blvd.
Fremont,  CA  94538
Correspondent Contact Dan Krause
Regulation Number870.2910
Classification Product Code
DRG  
Date Received01/23/2017
Decision Date 03/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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