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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, catheter control, steerable
510(k) Number K032937
Device Name NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
Applicant
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Applicant Contact PETER A TAKES
Correspondent
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Correspondent Contact PETER A TAKES
Regulation Number870.1290
Classification Product Code
DXX  
Date Received09/22/2003
Decision Date 07/01/2004
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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