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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
Device Name CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD
DIAMOND BAR,  CA  91765
Applicant Contact WAYNE R HOHMAN
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD
DIAMOND BAR,  CA  91765
Correspondent Contact WAYNE R HOHMAN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/23/2012
Decision Date 05/07/2012
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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