FDA 510(k) Application Details - K113246

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K113246
Device Name	Bone Grafting Material, Animal Source
Applicant	NIBEC COMPANY, LIMITED 4568 W. 1ST STREET SUITE 104 LOS ANGELES, CA 90004 US Other 510(k) Applications for this Company
Contact	DANIEL NAM Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2011
Decision Date	01/16/2013
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