FDA 510(k) Application Details - K113282

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K113282
Device Name	Bone Grafting Material, Synthetic
Applicant	RIEMSER ARZEIMITTEL AG 5105 FAIROAKS RD DURHAM, NC 27712 US Other 510(k) Applications for this Company
Contact	James M Clinton Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	LYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2011
Decision Date	09/20/2012
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