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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 K142377
Device Name The OnControl Bone Marrow Biopsy System by Vidacare
Applicant
VIDACARE LLC
4350 LOCKHILL SELMA RD.
SHAVANO PARK,  TX  78249
Applicant Contact DIANA MONTEZ
Correspondent
VIDACARE LLC
4350 LOCKHILL SELMA RD.
SHAVANO PARK,  TX  78249
Correspondent Contact DIANA MONTEZ
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received08/26/2014
Decision Date 12/17/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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