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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 K162989
Device Name Rusch Simplastic Foley Catheters
Applicant
TELEFLEX MEDICAL, INC.
3015 CARRINGTON MILLS BLVD
MORRISVILLE,  NC  27560
Applicant Contact LORI PFOHL
Correspondent
TELEFLEX MEDICAL, INC.
3015 CARRINGTON MILLS BLVD
MORRISVILLE,  NC  27560
Correspondent Contact LORI PFOHL
Regulation Number876.5130
Classification Product Code
EZL  
Date Received10/27/2016
Decision Date 02/24/2017
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
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