FDA 510(k) Application Details - K133033

Device Classification Name	Device, Iontophoresis, Other Uses   More FDA Info for this Device
510(K) Number	K133033
Device Name	Device, Iontophoresis, Other Uses
Applicant	HIDREX GMBH 2611 SHARK CIRCLE TEXAS CITY, TX 77591 US Other 510(k) Applications for this Company
Contact	STEFANIE D BANKSTON 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	09/26/2013
Decision Date	04/08/2015
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