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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 K160446
Device Name MCP Bone Putty
Applicant
Biostructures, LLC
1201 Dove St.
Suite 470
Newport Beach,  CA  92660
Applicant Contact John Brunelle
Correspondent
Trisler Consulting
5600 Wisconsin Ave.
Chevy Chase,  MD  20815
Correspondent Contact Patty J. Trisler
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/17/2016
Decision Date 11/07/2016
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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