FDA 510(k) Application Details - K190034

Device Classification Name	More FDA Info for this Device
510(K) Number	K190034
Device Name	REMY Medical Therapy Laser System
Applicant	Footdocprenur, LLC 1803 Country Club Drive Cherry Hill, NJ 08003 US Other 510(k) Applications for this Company
Contact	David Zuckerman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2019
Decision Date	05/15/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review