THE VITA 2 DISPOSABLE DIALYZER— 510(k) K801634

Name: FDA 510(k) clearance K801634
Creator: U.S. Food and Drug Administration
Published: 1980-12-17

Substantially Equivalent

Bellco Artifidial Organ Spec., Inc.

FDA 510(k) clearance K801634 for THE VITA 2 DISPOSABLE DIALYZER, Substantially Equivalent on 1980-12-17. Applicant: Bellco Artifidial Organ Spec., Inc.. Device class: 2.

Clearance details

Applicant: Bellco Artifidial Organ Spec., Inc.
Product code: Code FHS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-07-15
Decision date: 1980-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.