FILTER, EXTRACORPOREAL BLOOD HOLDER— 510(k) K781861

Name: FDA 510(k) clearance K781861
Creator: U.S. Food and Drug Administration
Published: 1978-11-15

Substantially Equivalent

Surgikos, Inc.

FDA 510(k) clearance K781861 for FILTER, EXTRACORPOREAL BLOOD HOLDER, Substantially Equivalent on 1978-11-15. Applicant: Surgikos, Inc.. Device class: 1.

Clearance details

Applicant: Surgikos, Inc.
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1978-11-06
Decision date: 1978-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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