FDA 510(k) Application Details - K151692

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K151692
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	BioArchitects USA, LLC 219 East 69th Street Suite 2K New York, NY 10021 US Other 510(k) Applications for this Company
Contact	Mark E. Ulrich 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	06/23/2015
Decision Date	11/20/2015
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