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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
Model EPIFLO-15 & EPIFLO-7
Device Name EPIFLO(R)
Original Applicant
3401 enterprise pkwy
suite 340
beachwood,  OH  44122
Original Contact srinivasan sarangapani
Regulation Number878.5650
Classification Product Code
Date Received03/13/2012
Decision Date 04/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes