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FDA 510(k) Application Details - K200441
Device Classification Name
More FDA Info for this Device
510(K) Number
K200441
Device Name
UroLift Advanced Tissue Control (ATC) System
Applicant
NeoTract, Inc.
4155 Hopyard Rd.
Pleasanton, CA 94588 US
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Contact
Brian Gall
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/24/2020
Decision Date
06/05/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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