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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K111018
Device Name POLYFUSE - NEUROBONE
Applicant
Atpac Medical, LLC
848 N Rainbow Blvd.
Las Vegas,  NV  89107
Applicant Contact GARY MALINOWSKI
Correspondent
Atpac Medical, LLC
848 N Rainbow Blvd.
Las Vegas,  NV  89107
Correspondent Contact GARY MALINOWSKI
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/12/2011
Decision Date 02/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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