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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 K120764
Device Name EPIFLO(R)
Original Applicant
NEOGENIX, LLC
3401 enterprise pkwy
suite 340
beachwood,  OH  44122
Original Contact srinivasan sarangapani
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received03/13/2012
Decision Date 04/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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