MAKY 21.1 DIALYZER REPROCESSING SYSTEM— 510(k) K024076

Name: FDA 510(k) clearance K024076
Creator: U.S. Food and Drug Administration
Published: 2003-09-26

Substantially Equivalent

Hdc Maquinolas, LLC

FDA 510(k) clearance K024076 for MAKY 21.1 DIALYZER REPROCESSING SYSTEM, Substantially Equivalent on 2003-09-26. Applicant: Hdc Maquinolas, LLC. Device class: 2.

Clearance details

Applicant: Hdc Maquinolas, LLC
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2002-12-10
Decision date: 2003-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pearland, TX, US

Download summary PDF View on FDA.gov ↗

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