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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K111087
Device Name FOUNDATION
Applicant
Olympus Terumo Biomaterials Corporation
5600 Wisonsin Ave.,
#509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
Olympus Terumo Biomaterials Corporation
5600 Wisonsin Ave.,
#509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/19/2011
Decision Date 11/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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