FDA 510(k) Application Details - K082286

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K082286
Device Name Bone Grafting Material, Synthetic
Applicant GRAFTYS
415 RUE CHARLES NICOLAS LEDOUX
EIFFEL PARK BAT D
AIX EN PROVENCE 13854 FR
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Contact ANTHONY LE NAOUR
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 08/11/2008
Decision Date 02/24/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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