FDA 510(k) Application Details - K081561

Device Classification Name	Bone Grafting Material, Synthetic   More FDA Info for this Device
510(K) Number	K081561
Device Name	Bone Grafting Material, Synthetic
Applicant	OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 CENTER VALLEY, PA 18034-0610 US Other 510(k) Applications for this Company
Contact	STACY A KLUESNER 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	06/03/2008
Decision Date	07/28/2008
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