FDA 510(k) Application Details - K073006

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K073006
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	TAKIRON CO., LTD 7-1-19, MINATOJIMAMINAMIMACHI, CHUO-KU, KOBE, HYOGO 650-0047 JP Other 510(k) Applications for this Company
Contact	KUNIHIRO HATA 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	10/24/2007
Decision Date	05/29/2008
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