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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 K200441
Device Name UroLift Advanced Tissue Control (ATC) System
Applicant
Neotract, Inc.
4155 Hopyard Rd.
Pleasanton,  CA  94588
Applicant Contact Brian Gall
Correspondent
Neotract, Inc.
4155 Hopyard Rd.
Pleasanton,  CA  94588
Correspondent Contact Brian Gall
Regulation Number876.5530
Classification Product Code
PEW  
Date Received02/24/2020
Decision Date 06/05/2020
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
Predetermined Change
Control Plan Authorized		 No
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