FDA 510(k) Application Details - K170637

Device Classification Name	More FDA Info for this Device
510(K) Number	K170637
Device Name	sensiFirm
Applicant	EL Global Trade Ltd 8 Tzoran St, P.O. Box 8242 Netanya 4250608 IL Other 510(k) Applications for this Company
Contact	Yael Liebes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2017
Decision Date	07/14/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review