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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 K120550
Models FG-5400-00, FG-5600-00
Device Name CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
Original Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd
diamond bar,  CA  91765
Original Contact wayne r hohman
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/23/2012
Decision Date 05/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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