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FDA 510(k) Application Details - K190987
Device Classification Name
More FDA Info for this Device
510(K) Number
K190987
Device Name
Uroject12 Syringe Lever
Applicant
UroGen Pharma Ltd.
9 Ha`Ta`asiya Street
RaÆanana 4365405 IL
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Contact
Liz Schindel
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QBL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2019
Decision Date
12/02/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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