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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, nephrostomy
510(k) Number K063632
Device Name X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
Applicant
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Applicant Contact TERRI MORRIS
Correspondent
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Correspondent Contact TERRI MORRIS
Classification Product Code
LJE  
Date Received12/06/2006
Decision Date 01/05/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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