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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 K020863
Device Name CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
Applicant
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Applicant Contact WILLIAM WELCH
Correspondent
BIOSENSE WEBSTER, INC.
3333 DIAMOND CANYON RD.
DIAMOND BAR,  CA  91765
Correspondent Contact WILLIAM WELCH
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/18/2002
Decision Date 01/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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