Uroject12 Syringe Lever— 510(k) K180345

Substantially Equivalent

Urogen Pharma, Ltd.

FDA 510(k) clearance K180345 for Uroject12 Syringe Lever, Substantially Equivalent on 2018-10-17. Applicant: Urogen Pharma, Ltd..

Clearance details

Applicant
Urogen Pharma, Ltd.
Product code
Code QBL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ra’Anana, IL
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