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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 K110368
Device Name NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
Applicant
Novabone Products, LLC
13631 Progress Blvd.
Suite 600
Alachua,  FL  32615
Applicant Contact DAVID M GAISSER
Correspondent
Novabone Products, LLC
13631 Progress Blvd.
Suite 600
Alachua,  FL  32615
Correspondent Contact DAVID M GAISSER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/08/2011
Decision Date 04/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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