FDA 510(k) Application Details - K201454

Device Classification Name	More FDA Info for this Device
510(K) Number	K201454
Device Name	DSG Connect Technology
Applicant	SpineGuard, S.A. 10 Cours Louis Lumiere Vincennes 94300 FR Other 510(k) Applications for this Company
Contact	Stephane Bette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2020
Decision Date	02/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review