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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 K091321
Device Name OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Applicant
Bacterin International, Inc.
600 Cruiser Ln
Belgrade,  MT  59714
Applicant Contact HOWARD J SCHRAYER
Correspondent
Bacterin International, Inc.
600 Cruiser Ln
Belgrade,  MT  59714
Correspondent Contact HOWARD J SCHRAYER
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received05/05/2009
Decision Date 09/11/2009
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
Recalls CDRH Recalls
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