FDA 510(k) Application Details - K152204

Device Classification Name	More FDA Info for this Device
510(K) Number	K152204
Device Name	VS3-IR system
Applicant	VISIONSENSE LTD 20 HAMAGSHIMIM ST PETACH TIKVA, HAMERKAZ 49348 IL Other 510(k) Applications for this Company
Contact	ALEX CHANIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2015
Decision Date	10/28/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review