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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 K051760
Device Name NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
Applicant
Stereotaxis, Inc.
4041 Forest Park Ave.
Saint Louis,  MO  63108
Applicant Contact PETER A TAKES
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Regulation Number870.1290
Classification Product Code
DXX  
Date Received06/29/2005
Decision Date 05/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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