ASSIST HEADER CLEANER— 510(k) K043126

Name: FDA 510(k) clearance K043126
Creator: U.S. Food and Drug Administration
Published: 2005-02-03

Substantially Equivalent

Alcavis International, Inc.

FDA 510(k) clearance K043126 for ASSIST HEADER CLEANER, Substantially Equivalent on 2005-02-03. Applicant: Alcavis International, Inc.. Device class: 2.

Clearance details

Applicant: Alcavis International, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2004-11-12
Decision date: 2005-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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