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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 K053151
Device Name RUBICOR MAGIC BREAST BIOPSY DEVICE
Applicant
RUBICOR MEDICAL, INC.
849 VETERANS BLVD.
REDWOOD CITY,  CA  94063
Applicant Contact ROBERT J CHIN
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/10/2005
Decision Date 11/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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