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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K223266
Device Name Hilzo Esophageal Stents
Applicant
Thoracent, Inc.
120 New York Ave.
Unit 6w
Huntington,  NY  11743
Applicant Contact Brian Lynch
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number878.3610
Classification Product Code
ESW  
Date Received10/24/2022
Decision Date 01/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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