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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 K192034
Device Name HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
Applicant
Pathway, LLC
8779 Cottonwood Avenue, Suite 105
Santee,  CA  92071
Applicant Contact David Stroup
Correspondent
Pathway, LLC
8779 Cottonwood Avenue, Suite 105
Santee,  CA  92071
Correspondent Contact Aaron Rogers
Regulation Number876.5130
Classification Product Code
EZL  
Date Received07/30/2019
Decision Date 04/21/2020
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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