FDA 510(k) Application Details - K062834

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K062834
Device Name Bone Grafting Material, Synthetic
Applicant GENOSS CO., LTD.
28711 JAEGER DRIVE
LAGUNA NIGUEL, CA 92677 US
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Contact KLASS BESSELING
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 09/21/2006
Decision Date 04/24/2007
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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