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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K112428
Device Name NOVABONE DENTAL MORSELS - 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 Number872.3930
Classification Product Code
LYC  
Date Received08/23/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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