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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Malecot
510(k) Number K070879
Device Name BARD MALECOT AND PEZZER DRAINS
Applicant
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Applicant Contact JOHN KNORPP
Correspondent
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Correspondent Contact JOHN KNORPP
Regulation Number876.5090
Classification Product Code
FEW  
Date Received03/30/2007
Decision Date 04/24/2007
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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