WAREXIN RECOMMENDED ALTERNATIVE DIALYZ— 510(k) K843520

Name: FDA 510(k) clearance K843520
Creator: U.S. Food and Drug Administration
Published: 1984-10-04

Substantially Equivalent

Mesa Medical, Inc.

FDA 510(k) clearance K843520 for WAREXIN RECOMMENDED ALTERNATIVE DIALYZ, Substantially Equivalent on 1984-10-04. Applicant: Mesa Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mesa Medical, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1984-09-07
Decision date: 1984-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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