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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 K233013
Device Name 2-Way 100% Silicone Cleartract Catheter
Applicant
Silq Technologies Corporation
323 Sunny Isles Blvd
Sunny Isles Beach,  FL  33160
Applicant Contact D. Verne Sharma
Correspondent
Pathway LLC
8779 Cottonwood Avenue
Suite 105
Santee,  CA  92071
Correspondent Contact Aaron Rogers
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/22/2023
Decision Date 01/23/2024
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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