FDA 510(k) Application Details - K161446

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K161446
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	Ceremed , Inc. 3643 Lenawee Ave Los Angeles, CA 90016 US Other 510(k) Applications for this Company
Contact	Chelsea Mitchell 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	05/25/2016
Decision Date	09/27/2016
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