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510(k) K190987

Uroject12 Syringe Lever by Urogen Pharma, Ltd. — Product Code QBL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 2, 2019
Date Received: April 15, 2019
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Piston Syringe Lever
Device Class: Class II
Regulation Number: 880.5860
Review Panel: HO
Submission Type

Controlled compression of a piston syringe