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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 K193269
Device Name UroLift System (UL400)
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 Received11/26/2019
Decision Date 12/20/2019
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
Recalls CDRH Recalls
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