FDA 510(k) Application Details - K031813

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K031813
Device Name	Bone Grafting Material, Synthetic
Applicant	ISOTIS NV 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE 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	06/12/2003
Decision Date	08/20/2004
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