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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Coude
510(k) Number K173596
Device Name Rusch Intermittent Urethral Catheters
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Amanda Webb
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Amanda Webb
Regulation Number876.5130
Classification Product Code
EZC  
Subsequent Product Code
EZD  
Date Received11/21/2017
Decision Date 01/29/2018
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
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