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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 K093068
Device Name FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
Applicant
C.R. Bard, Inc.
1415 W. 3rd
P.O Box 1740
Tempe,  AZ  85280 -1740
Applicant Contact CINDY MOSS
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/30/2009
Decision Date 11/10/2009
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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