FDA 510(k) Application Details - K193383

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K193383
Device Name	Orthosis, Cranial
Applicant	HeadStart, Ltd. 1550 E. Higgins Road, Suite 123 Elk Grove Village, IL 60007 US Other 510(k) Applications for this Company
Contact	James McCartney 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	12/05/2019
Decision Date	06/07/2021
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