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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K073399
Device Name TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
Applicant
ENVISIONEERING, LLC.
1982 INNERBELT BUSINESS CTR DR
ST. LOUIS,  MO  63114
Applicant Contact DAVID KENNEDY
Correspondent
ENVISIONEERING, LLC.
1982 INNERBELT BUSINESS CTR DR
ST. LOUIS,  MO  63114
Correspondent Contact DAVID KENNEDY
Regulation Number876.1075
Classification Product Code
FCG  
Subsequent Product Code
ITX  
Date Received12/04/2007
Decision Date 12/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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