FDA 510(k) Application Details - K203134

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K203134
Device Name	Orthosis, Cranial
Applicant	Symbion Logistics, LLC 1119 W Geneva Dr Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Roselle Abad 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	10/19/2020
Decision Date	07/01/2022
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