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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 K021336
Device Name NOVABONE-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 Number888.3045
Classification Product Code
MQV  
Date Received04/26/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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