FDA 510(k) Application Details - K983009

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K983009
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	ETEX CORP. 350 MASSACHUSETTES AVE., 4FLR CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	MICHAEL SCHTTENBERG Other 510(k) Applications for this Contact
Regulation Number	882.5300   More FDA Info for this Regulation Number
Classification Product Code	GXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/1998
Decision Date	11/25/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review