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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Transprostatic Tissue Retractor System
510(k) Number K172359
Device Name UroLift System (UL500)
Applicant
NeoTract, Inc.
4473 Willow Road
Suite 100
Pleasanton,  CA  94588
Applicant Contact Louis-Pierre Marcoux
Correspondent
NeoTract, Inc.
4473 Willow Road
Suite 100
Pleasanton,  CA  94588
Correspondent Contact Louis-Pierre Marcoux
Regulation Number876.5530
Classification Product Code
PEW  
Date Received08/04/2017
Decision Date 08/18/2017
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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