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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K821745
Device Name BARDEX ALL SILICONE PEDIATRIC CATHETER
Applicant
C.R Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Correspondent
C.R Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Regulation Number876.5130
Classification Product Code
KOD  
Date Received06/14/1982
Decision Date 06/24/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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