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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 K053387
Device Name PERIOGLAS BONE GRAFT PARTICULATE
Applicant
Novabone Products, LLC
13709 Progress Blvd.
#33
Alachua,  FL  32615
Applicant Contact DAVID M GAISSER
Correspondent
Novabone Products, LLC
13709 Progress Blvd.
#33
Alachua,  FL  32615
Correspondent Contact DAVID M GAISSER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/05/2005
Decision Date 02/14/2006
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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