FDA 510(k) Application Details - K201426

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K201426
Device Name	Orthosis, Cranial
Applicant	Otto Bock Healthcare LP 3820 West Great Lakes Drive Salt Lake City, UT 84120 US Other 510(k) Applications for this Company
Contact	Caleb Beck 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	05/29/2020
Decision Date	03/26/2021
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