FDA 510(k) Application Details - K093122

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K093122
Device Name Bone Grafting Material, Synthetic
Applicant BIOMATLANTE
5, RUE EDOUARD BELIN
ZA LES QUATRE NATIONS
VIGNEUX DE BRETAGNE 44360 FR
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Contact JEANNE CHAMOUSSET-ROMAN
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 10/02/2009
Decision Date 03/15/2010
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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