FDA 510(k) Application Details - K122894

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K122894
Device Name	Bone Grafting Material, Animal Source
Applicant	GEISTLICH PHARMA AG 555 TWELFTH STREET, NW WASHINGTON, DC 20004-1206 US Other 510(k) Applications for this Company
Contact	DANIEL A KRACOV 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	09/20/2012
Decision Date	02/15/2013
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