FDA 510(k) Application Details - K201906

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K201906
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Carol Cole Company dba NuFACE 1325 Sycamore Avenue, Suite A Vista, CA 92081 US Other 510(k) Applications for this Company
Contact	Danielle Barker Fernandes Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NFO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2020
Decision Date	02/24/2021
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