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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 K221625
Device Name 2-Way 100% Silicone ClearTract Catheter
Applicant
Silq Technologies Corporation
323 Sunny Isles Blvd.
Sunny Isles Beach,  FL  33160
Applicant Contact Sigi Caron
Correspondent
Silq Technologies Corporation
323 Sunny Isles Blvd.
Sunny Isles Beach,  FL  33160
Correspondent Contact Sigi Caron
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/06/2022
Decision Date 07/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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