FDA 510(k) Application Details - K080418

Device Classification Name	Bone Grafting Material, Human Source   More FDA Info for this Device
510(K) Number	K080418
Device Name	Bone Grafting Material, Human Source
Applicant	REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 ALACHUA, FL 32616-2650 US Other 510(k) Applications for this Company
Contact	TRAVIS AROLA 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	02/15/2008
Decision Date	04/30/2008
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