Cystoject Syringe Lever— 510(k) K203321

Substantially Equivalent

Urogen Pharma, Ltd.

FDA 510(k) clearance K203321 for Cystoject Syringe Lever, Substantially Equivalent on 2020-12-09. Applicant: Urogen Pharma, Ltd..

Clearance details

Applicant: Urogen Pharma, Ltd.
Product code: Code QBL
Advisory panel: General Hospital
Date received: 2020-11-12
Decision date: 2020-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Ra'Anana, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.