FDA 510(k) Application Details - K021889

Device Classification Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction   More FDA Info for this Device
510(K) Number	K021889
Device Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant	SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. CLEVELAND, OH 44103 US Other 510(k) Applications for this Company
Contact	CAMERON J FORDYCE 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	06/07/2002
Decision Date	10/16/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review