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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 K082681
Device Name VACORA VACUUM ASSISTED BIOPSY SYSTEM
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Applicant Contact CINDY MOSS
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Correspondent Contact CINDY MOSS
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/15/2008
Decision Date 10/15/2008
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
Recalls CDRH Recalls
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