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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 K182511
Device Name SimplCath
F&S Medical Solutions, LLC
10221 Woodridge Lane
Omaha,  NE  68124
Applicant Contact Sonia M. Rocha-Sanchez
915 SW Rimrock Way STE 201 PMB 402
Redmond,  OR  97756
Correspondent Contact Tom Renner
Regulation Number876.5130
Classification Product Code
Date Received09/12/2018
Decision Date 03/20/2019
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