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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 K033994
Device Name NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
Applicant
Novabone Products, LLC
One Progress Blvd.
Suite 33
Alachua,  FL  32615
Applicant Contact DAVID M GAISSER
Correspondent
Novabone Products, LLC
One Progress Blvd.
Suite 33
Alachua,  FL  32615
Correspondent Contact DAVID M GAISSER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/24/2003
Decision Date 03/25/2004
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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