FDA 510(k) Application Details - K130059

Device Classification Name	More FDA Info for this Device
510(K) Number	K130059
Device Name	ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
Applicant	IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. 1914 J.N. PEASE PLACE CHARLOTTE, NC 28262 US Other 510(k) Applications for this Company
Contact	ELISSA BURG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2013
Decision Date	07/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review