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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 K053194
Device Name NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
Applicant
Biosense Webster, Inc.
2400 Via Carrillo
Palos Verdes Estates,  CA  90274
Applicant Contact SIGI CARON
Correspondent
Biosense Webster, Inc.
2400 Via Carrillo
Palos Verdes Estates,  CA  90274
Correspondent Contact SIGI CARON
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/15/2005
Decision Date 03/09/2006
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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