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510(k) K190742

EPIFLO-28 by Neogenix, LLC Dba Ogenix — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
March 22, 2019
Clearance Type
Traditional
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

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  • K050156 — WHS-1000 WOUND HEALING SYSTEM (June 17, 2005)
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  • K020466 — HEC 1000 (May 8, 2002)