DIALYZER REPROCESSING SYSTEM— 510(k) K944492

Name: FDA 510(k) clearance K944492
Creator: U.S. Food and Drug Administration
Published: 1995-08-28

Substantially Equivalent

G.E.M. Water Systems

FDA 510(k) clearance K944492 for DIALYZER REPROCESSING SYSTEM, Substantially Equivalent on 1995-08-28. Applicant: G.E.M. Water Systems. Device class: 2.

Clearance details

Applicant: G.E.M. Water Systems
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-13
Decision date: 1995-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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