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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 K103359
Device Name FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
Applicant
C.R. Bard, Inc.
1415 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact CINDY MOSS
Correspondent
C.R. Bard, Inc.
1415 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact CINDY MOSS
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/16/2010
Decision Date 12/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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