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FDA 510(k) Application Details - DEN130023
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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