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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 AVENUE,
#509
CHEVY CHASE,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
OLYMPUS TERUMO BIOMATERIALS CORPORATION
5600 WISONSIN AVENUE,
#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
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