FDA 510(k) Application Details - K053199

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K053199
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	SYNTHES (USA) 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	Lisa Boyle Other 510(k) Applications for this Contact
Regulation Number	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2005
Decision Date	12/14/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review