FDA 510(k) Application Details - K220735

Device Classification Name	Media, Electroconductive   More FDA Info for this Device
510(K) Number	K220735
Device Name	Media, Electroconductive
Applicant	Premier North America Inc. 3301 SW 42nd Street Fort Lauderdale, FL 33312-6828 US Other 510(k) Applications for this Company
Contact	Ellis Tamari Other 510(k) Applications for this Contact
Regulation Number	882.1275   More FDA Info for this Regulation Number
Classification Product Code	GYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2022
Decision Date	09/15/2023
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