FDA 510(k) Application Details - K113645

Device Classification Name	Bone Grafting Material, Human Source   More FDA Info for this Device
510(K) Number	K113645
Device Name	Bone Grafting Material, Human Source
Applicant	BIOMET INTERPORE CROSS 181 TECHNOLOGY DRIVE IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	KATHLEEN OLIVARES Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NUN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2011
Decision Date	01/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review