FDA 510(k) Application Details - K974206

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K974206
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD PAOLI, PA 19301-1222 US Other 510(k) Applications for this Company
Contact	SHERI MUSGNUNG Other 510(k) Applications for this Contact
Regulation Number	882.5320   More FDA Info for this Regulation Number
Classification Product Code	GWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/1997
Decision Date	03/16/1998
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