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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 K122659
Device Name VDRIVE W/V-SONO
Applicant
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Applicant Contact HORWITZ
Correspondent
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Correspondent Contact HORWITZ
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXX  
Date Received08/31/2012
Decision Date 07/26/2013
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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