FDA 510(k) Application Details - K012589

Device Classification Name	Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K012589
Device Name	Methyl Methacrylate For Cranioplasty
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	THOMAS M MAGUIRE 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	08/10/2001
Decision Date	02/07/2002
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