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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K181979
Device Name Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Suite 600n
Morrisville,  NC  27560
Applicant Contact Sirisha Kommana
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Suite 600n
Morrisville,  NC  27560
Correspondent Contact Sirisha Kommana
Regulation Number876.5130
Classification Product Code
KOD  
Date Received07/25/2018
Decision Date 05/24/2019
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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