FDA 510(k) Application Details - K170291

Device Classification Name	Device, Iontophoresis, Other Uses   More FDA Info for this Device
510(K) Number	K170291
Device Name	Device, Iontophoresis, Other Uses
Applicant	SOTERIX MEDICAL,INC. 237 W 35 ST, 1401 NEW YORK, NY 10001 US Other 510(k) Applications for this Company
Contact	ABHISHEK DATTA Other 510(k) Applications for this Contact
Regulation Number	890.5525   More FDA Info for this Regulation Number
Classification Product Code	EGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2017
Decision Date	05/01/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review