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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K070582
Device Name BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact SKIP RIMER
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
MJC  
Date Received03/01/2007
Decision Date 12/07/2007
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
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