CIRCUFLOW 5150— 510(k) K123959

Substantially Equivalent

Devon Medical, Inc.

FDA 510(k) clearance K123959 for CIRCUFLOW 5150, Substantially Equivalent on 2013-02-28. Applicant: Devon Medical, Inc.. Device class: 2.

Clearance details

Applicant: Devon Medical, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2012-12-21
Decision date: 2013-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, 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.