FDA 510(k) Application Details - K250420

Device Classification Name	Dura Substitute   More FDA Info for this Device
510(K) Number	K250420
Device Name	Dura Substitute
Applicant	Helios Biomedical Inc. 11 Dellbrook Road Weston, MA 02493 US Other 510(k) Applications for this Company
Contact	Yiannis Monovoukas Other 510(k) Applications for this Contact
Regulation Number	882.5910   More FDA Info for this Regulation Number
Classification Product Code	GXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2025
Decision Date	05/14/2025
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