FDA 510(k) Application Details - K103699

Device Classification Name	Bone Grafting Material, Human Source   More FDA Info for this Device
510(K) Number	K103699
Device Name	Bone Grafting Material, Human Source
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	SHING JEN TAI, PHD 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	12/20/2010
Decision Date	08/12/2011
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