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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K060047
Device Name CARTO RMT EP NAVIGATION SYSTEM V8
Applicant
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Applicant Contact DIANA THORSON
Correspondent
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Correspondent Contact DIANA THORSON
Regulation Number870.1220
Classification Product Code
DRF  
Date Received01/06/2006
Decision Date 06/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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