FDA 510(k) Application Details - K013764

Device Classification Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction   More FDA Info for this Device
510(K) Number	K013764
Device Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant	OSTEOGENICS BIOMEDICAL, INC. 6401 MEADOWS WEST DR. FORT WORTH, TX 76132 US Other 510(k) Applications for this Company
Contact	RICHARD A HAMER Other 510(k) Applications for this Contact
Regulation Number	878.3500   More FDA Info for this Regulation Number
Classification Product Code	KKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2001
Decision Date	05/16/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review