FDA 510(k) Application Details - K130501

Device Classification Name	More FDA Info for this Device
510(K) Number	K130501
Device Name	INTENSIF
Applicant	ENDYMED MEDICAL LTD HAAVODA 31 ST. BINYAMINA 30500 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	OUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2013
Decision Date	03/13/2014
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