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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 K101860
Device Name NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
Applicant
NovaBone Products, LLC
13631 PROGRESS BLVD
SUITE 600
ALACHUA,  FL  32615
Applicant Contact DAVID M GALSSER
Correspondent
NovaBone Products, LLC
13631 PROGRESS BLVD
SUITE 600
ALACHUA,  FL  32615
Correspondent Contact DAVID M GALSSER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/02/2010
Decision Date 09/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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