FDA 510(k) Application Details - K083016

Device Classification Name	Device, Iontophoresis, Other Uses   More FDA Info for this Device
510(K) Number	K083016
Device Name	Device, Iontophoresis, Other Uses
Applicant	MICROLAB AMERICAS INC 1468 HARWELL AVE CROFTON, MD 2114 US Other 510(k) Applications for this Company
Contact	E J SMITH 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	10/09/2008
Decision Date	06/16/2009
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