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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 K152071
Device Name NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
Applicant
Novabone Products, LLC
13510 NW Us Highway 441
Alachua,  FL  32615
Applicant Contact RICHARD A. DAVIS
Correspondent
Simpson Regulatory Solutions, LLC
4401 NW 18th Place
Gainesville,  FL  32605
Correspondent Contact LISA C. SIMPSON
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/27/2015
Decision Date 08/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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