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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 K040783
Device Name FOUNDATION
Applicant
TERUMO CORP.
1425 K STREET N.W.
SUITE 1100
WASHINGTON,  DC  20005
Applicant Contact KEITH A BARRITT, ESQ.
Correspondent
TERUMO CORP.
1425 K STREET N.W.
SUITE 1100
WASHINGTON,  DC  20005
Correspondent Contact KEITH A BARRITT, ESQ.
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/26/2004
Decision Date 10/13/2004
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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