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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 K112468
Device Name THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
Applicant
REGULATORY SPECIALISTS, INC.
3722 AVE SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
REGULATORY SPECIALISTS, INC.
3722 AVE SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
OAR  
Date Received08/26/2011
Decision Date 10/20/2011
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
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