FDA 510(k) Application Details - K131385

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K131385
Device Name	Bone Grafting Material, Synthetic
Applicant	Degradable Solutions AG 901 KING STREET SUITE 101 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	DEBORAH LAVOIE GRAYESKI 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	05/14/2013
Decision Date	09/27/2013
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