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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fibrin sealant preparation device
510(k) Number BK140093
Tradename Evicel Application Device
Device Name Fibrin Sealant Preparation Device
Original Applicant
Omrix Biopharmaceuticals Ltd.
po box 151, route22 west
somerville,  NJ  08876 0151
Regulation Number880.5860
Classification Product Code
MZM  
Date Received02/12/2014
Decision Date 09/03/2014
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
In Vitro Product No
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