ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003— 510(k) K093718

Name: FDA 510(k) clearance K093718
Creator: U.S. Food and Drug Administration
Published: 2010-02-22

Substantially Equivalent

Zutron Medical, LLC

FDA 510(k) clearance K093718 for ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003, Substantially Equivalent on 2010-02-22. Applicant: Zutron Medical, LLC. Device class: 1.

Clearance details

Applicant: Zutron Medical, LLC
Product code: Code FCY
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2009-12-02
Decision date: 2010-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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