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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K032673
Device Name IMMIX PLASTIFILM
Original Applicant
OSTEOBIOLOGICS, INC.
university business park
12500 network, suite 112
san antonio,  TX  78249 3308
Original Contact gabriele g niederauer
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/02/2003
Decision Date 10/02/2003
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 No
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