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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 K013966
Device Name APATIGHT-TCP BONE GRAFT SUBSTITUTE
Applicant
Cerabio, LLC
N4660 1165th St.
Prescott,  WI  54021 -7644
Applicant Contact JAMES J CASSIDY
Correspondent
Cerabio, LLC
N4660 1165th St.
Prescott,  WI  54021 -7644
Correspondent Contact JAMES J CASSIDY
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/03/2001
Decision Date 05/16/2002
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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