FDA 510(k) Application Details - K040783

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K040783
Device Name Bone Grafting Material, Synthetic
Applicant TERUMO CORP.
1425 K STREET N.W.
SUITE 1100
WASHINGTON, DC 20005 US
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Contact KEITH A BARRITT, ESQ.
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 03/26/2004
Decision Date 10/13/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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