FDA 510(k) Application Details - K161199

Device Classification Name	More FDA Info for this Device
510(K) Number	K161199
Device Name	EndyMed Contour Handpiece
Applicant	ENDYMED MEDICAL LTD. 12 LESHEM STREET NORTH INDUSTRIAL PARK Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Yoram Levy 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	04/28/2016
Decision Date	08/01/2016
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