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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K170600
Device Name CARTO 3 EP Navigation System, Version 6.0 and Accessories
Applicant
Biosense Webster, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Phoung Chau
Correspondent
Biosense Webster, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Phoung Chau
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/01/2017
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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