JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve— 510(k) K210625

Name: FDA 510(k) clearance K210625
Creator: U.S. Food and Drug Administration
Published: 2021-09-10

Substantially Equivalent

Fujifilm Medwork GmbH

FDA 510(k) clearance K210625 for JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve, Substantially Equivalent on 2021-09-10. Applicant: Fujifilm Medwork GmbH. Device class: 2.

Clearance details

Applicant: Fujifilm Medwork GmbH
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-02
Decision date: 2021-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hochstadt, DE

Download summary PDF View on FDA.gov ↗

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