AUTOMATIC DIALYZER REPROCESSOR #ADR-22— 510(k) K820695

Name: FDA 510(k) clearance K820695
Creator: U.S. Food and Drug Administration
Published: 1982-04-29

Substantially Equivalent

Texas Medical Devices, Inc.

FDA 510(k) clearance K820695 for AUTOMATIC DIALYZER REPROCESSOR #ADR-22, Substantially Equivalent on 1982-04-29. Applicant: Texas Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Texas Medical Devices, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1982-03-12
Decision date: 1982-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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