FDA 510(k) Application Details - K180568

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K180568
Device Name	Orthosis, Cranial
Applicant	Eastern Cranial Affiliates, LLC 10523 Main Street Fairfax, VA 22030 US Other 510(k) Applications for this Company
Contact	Joseph Terpenning Other 510(k) Applications for this Contact
Regulation Number	882.5970   More FDA Info for this Regulation Number
Classification Product Code	MVA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2018
Decision Date	10/16/2018
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