FDA 510(k) Application Details - K011935

Device Classification Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes   More FDA Info for this Device
510(K) Number	K011935
Device Name	Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant	SALTON, INC. 1050 CONNECTICUT AVE., NW WASHINGTON, DC 20036-5339 US Other 510(k) Applications for this Company
Contact	GEORGIA C RAVITZ 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	06/21/2001
Decision Date	08/08/2001
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