FDA 510(k) Application Details - K130235

Device Classification Name	Bone Grafting Material, Human Source   More FDA Info for this Device
510(K) Number	K130235
Device Name	Bone Grafting Material, Human Source
Applicant	HANS BIOMED CORP. 5600 WISCONSIN AVENUE #509 CHEVY CHASE, MD 20815 US Other 510(k) Applications for this Company
Contact	PATSY J TRISLER, JD, RAC 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	01/30/2013
Decision Date	01/10/2014
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