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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K183461
Device Name Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
Applicant
Teleflex Medical, Inc
3015 Carrington Mill Blvd , Suite 600 North
Morrisville,  NC  27560
Applicant Contact Lori Pfohl
Correspondent
Teleflex Medical, Inc
3015 Carrington Mill Blvd , Suite 600 North
Morrisville,  NC  27560
Correspondent Contact Lori Pfohl
Regulation Number876.5130
Classification Product Code
GBM  
Subsequent Product Code
KOD  
Date Received12/14/2018
Decision Date 05/08/2019
Decision Substantially Equivalent - Kit (SESK)
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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