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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 K040047
Device Name POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
Applicant
Osteobiologics, Inc.
12500 Network Suite 112
San Antonio,  TX  78249
Applicant Contact GABRIELE G NIEDERAUER
Correspondent
Osteobiologics, Inc.
12500 Network Suite 112
San Antonio,  TX  78249
Correspondent Contact GABRIELE G NIEDERAUER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received01/12/2004
Decision Date 12/17/2004
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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