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510(k) K190987

Device
Uroject12 Syringe Lever
Applicant
UroGen Pharma Ltd.
510(k) number
K190987
Product code
QBL  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-02
Date received
2019-04-15
Regulation
880.5860
Classification name
Piston Syringe Lever
Medical specialty
General Hospital
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Liz Schindel
Address
9 Ha`Ta`Asiya St. Ra’Anana IL 4365405 4365405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QBL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203321Cystoject Syringe LeverUrogen Pharma, Ltd.2020-12-09
K180345Uroject12 Syringe LeverUrogen Pharma, Ltd.2018-10-17

Legacy Summary#

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FDA Review#

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