510(k) K120764

EPIFLO(R) by Neogenix, LLC — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
March 13, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type