FDA 510(k) Application Details - K180064

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K180064
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074 US Other 510(k) Applications for this Company
Contact	M. Beth Pashko 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	01/09/2018
Decision Date	07/27/2018
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