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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, double lumen female urethrographic
510(k) Number K910196
Device Name BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Applicant Contact DONNA J WILSON
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON,  GA  30014
Correspondent Contact DONNA J WILSON
Regulation Number876.5130
Classification Product Code
FGH  
Date Received01/16/1991
Decision Date 03/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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