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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 K163310
Device Name NovaBone IRM
Applicant
Novabone Products, LLC
13510 NW Us Hwy. 441
Alachua,  FL  32615
Applicant Contact Gregory Pomrink
Correspondent
Simpson Regulatory Solutions, LLC
4401 NW 18th Pl.
Gainesville,  FL  32605
Correspondent Contact Lisa C. Simpson
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/23/2016
Decision Date 01/18/2017
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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