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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K190742
Device Name EPIFLO-28
Applicant
Neogenix, LLC dba Ogenix
3401 Enterprise Pkwy, Suite 340
Beachwood,  OH  44122
Applicant Contact Srinivasan Sarangapani
Correspondent
Neogenix, LLC dba Ogenix
3401 Enterprise Pkwy, Suite 340
Beachwood,  OH  44122
Correspondent Contact Srinivasan Sarangapani
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received03/22/2019
Decision Date 12/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01291160
Reviewed by Third Party No
Combination Product No
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