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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, straight
510(k) Number K150345
Device Name Magic3 Go Intermittent Urinary Catheter
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Applicant Contact WILLIAM HEARD
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Correspondent Contact WILLIAM HEARD
Regulation Number876.5130
Classification Product Code
EZD  
Date Received02/11/2015
Decision Date 05/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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