FDA 510(k) Application Details - K171507

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K171507
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	Fin-ceramica faenza spa via ravegnana 186 Faenza 48018 IT Other 510(k) Applications for this Company
Contact	Marina Monticelli 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	05/23/2017
Decision Date	09/01/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review