FDA 510(k) Application Details - K182757

Device Classification Name	Electrode, Cutaneous   More FDA Info for this Device
510(K) Number	K182757
Device Name	Electrode, Cutaneous
Applicant	College Park Industries, Inc. 27955 College Park Drive Warren, MI 48088 US Other 510(k) Applications for this Company
Contact	Deborah Mackmin Other 510(k) Applications for this Contact
Regulation Number	882.1320   More FDA Info for this Regulation Number
Classification Product Code	GXY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	11/29/2018
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