GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS— 510(k) K896757

Name: FDA 510(k) clearance K896757
Creator: U.S. Food and Drug Administration
Published: 1990-08-30

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K896757 for GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS, Substantially Equivalent on 1990-08-30. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1989-12-01
Decision date: 1990-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.