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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 K070240
Device Name CARTO XP EP NAVIGATION SYSTEM, VERSION 9
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Applicant Contact NEELU MEDHEKAR
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Correspondent Contact NEELU MEDHEKAR
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/25/2007
Decision Date 05/04/2007
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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