EPIFLO-28— 510(k) K190742

Substantially Equivalent

Neogenix, LLC Dba Ogenix

FDA 510(k) clearance K190742 for EPIFLO-28, Substantially Equivalent on 2019-12-13. Applicant: Neogenix, LLC Dba Ogenix. Device class: 2.

Clearance details

Applicant: Neogenix, LLC Dba Ogenix
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 2019-03-22
Decision date: 2019-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beachwood, OH, 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.