DIALYZER, ULTRADIFFUSER, DISPOSABLE— 510(k) K770858

Name: FDA 510(k) clearance K770858
Creator: U.S. Food and Drug Administration
Published: 1977-06-14

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K770858 for DIALYZER, ULTRADIFFUSER, DISPOSABLE, Substantially Equivalent on 1977-06-14. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1977-05-09
Decision date: 1977-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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