FDA 510(k) Application Details - K192749

Device Classification Name	Device, Iontophoresis, Other Uses   More FDA Info for this Device
510(K) Number	K192749
Device Name	Device, Iontophoresis, Other Uses
Applicant	Dermadry Laboratories inc. 9223 Langelier Blvd Montreal H1P 3K9 CA Other 510(k) Applications for this Company
Contact	Maxime Calouche 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	09/30/2019
Decision Date	02/10/2020
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