PRE-BYPASS FILTER #EC-PBF SERIES— 510(k) K832594

Name: FDA 510(k) clearance K832594
Creator: U.S. Food and Drug Administration
Published: 1983-09-20

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K832594 for PRE-BYPASS FILTER #EC-PBF SERIES, Substantially Equivalent on 1983-09-20. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code KRJ
Device class: Class 2
Regulation: 21 CFR 870.4280
Advisory panel: Cardiovascular
Date received: 1983-08-02
Decision date: 1983-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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