FDA 510(k) Application Details - K033098

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K033098
Device Name Bone Grafting Material, Synthetic
Applicant IMPLADENT, LTD.
198-45 FOOTHILL AVE.
HOLLISWOOD, NY 11423 US
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Contact MAURICE VALEN
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 09/29/2003
Decision Date 04/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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