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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 K172247
Device Name Magic3 Go Intermittent Urinary Catheter
Applicant
C.R. Bard, Inc.
8195 Industrial Blvd
Covington,  GA  30014
Applicant Contact Nancy Underwood
Correspondent
C.R. Bard, Inc.
8195 Industrial Blvd
Covington,  GA  30014
Correspondent Contact Nancy Underwood
Regulation Number876.5130
Classification Product Code
EZD  
Date Received07/26/2017
Decision Date 09/20/2017
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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