FDA 510(k) Application Details - K182424

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K182424
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Carol Cole Company dba NuFACE 1325 Sycamore Ave. Suite A Vista, CA 92081 US Other 510(k) Applications for this Company
Contact	Donald Ellis 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	09/06/2018
Decision Date	12/18/2018
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