Cleared Special

EPIFLO(R)

K120764 · Neogenix, LLC · General & Plastic Surgery
Apr 2012
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K120764 is an FDA 510(k) clearance for the EPIFLO(R), a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Neogenix, LLC (Beachwood, US). The FDA issued a Cleared decision on April 27, 2012, 45 days after receiving the submission on March 13, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.

Submission Details

510(k) Number K120764 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2012
Decision Date April 27, 2012
Days to Decision 45 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KPJ — Chamber, Oxygen, Topical, Extremity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5650