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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
Original Applicant
OLYMPUS TERUMO BIOMATERIALS CORPORATION
5600 wisonsin avenue,
#509
chevy chase,  MD  20815
Original 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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