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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K121476
Device Name INFILL GRAFT DELIVERY SYSTEM
Original Applicant
PINNACLE SPINE GROUP, LLC
1601 elm st ste 1930
dallas,  TX  75201
Original Contact rebecca k pine
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/18/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
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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