FDA 510(k) Application Details - K103472

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K103472
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	Carol Cole Company 16405 SUMMER SAGE RD POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	BOB DUFFY 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	11/24/2010
Decision Date	11/07/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review