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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, biopsy
510(k) Number K113872
FOIA Releasable 510(k) K113872
Device Name THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
Applicant
VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
VIDACARE CORPORATION
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number876.1075
Classification Product Code
KNW  
Date Received12/30/2011
Decision Date 03/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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