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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
Applicant
PINNACLE SPINE GROUP, LLC
1601 Elm St Ste 1930
Dallas,  TX  75201
Applicant Contact Rebecca K Pine
Correspondent
PINNACLE SPINE GROUP, LLC
1601 Elm St Ste 1930
Dallas,  TX  75201
Correspondent Contact Rebecca K Pine
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/18/2012
Decision Date 08/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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