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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K043457
Device Name MODIFICATION TO ENDOVASCULAR GUIDE WIRE
Applicant
Stereotaxis, Inc.
4041 Forest Park Ave.
Saint Louis,  MO  63108
Applicant Contact GARY RAUVOLA
Correspondent
Stereotaxis, Inc.
4041 Forest Park Ave.
Saint Louis,  MO  63108
Correspondent Contact GARY RAUVOLA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/15/2004
Decision Date 02/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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