FDA 510(k) Application Details - DEN130023

Device Classification Name

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510(K) Number DEN130023
Device Name UROLIFT SYSTEM
Applicant NEOTRACT, INC.
4473 WILLOW ROAD
SUITE 100
PLEASANTON, CA 94588 US
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Contact Nancy E Isaac
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Regulation Number

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Classification Product Code PEW
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Date Received 03/07/2013
Decision Date 09/13/2013
Decision DENG -
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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