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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 K140946
Device Name NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
Applicant
Novabone Products, LLC
13510 NW Us Hwy. 441
Alachua,  FL  32615
Applicant Contact Lisa Simpson
Correspondent
Novabone Products, LLC
13510 NW Us Hwy. 441
Alachua,  FL  32615
Correspondent Contact Lisa Simpson
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/14/2014
Decision Date 08/22/2014
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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