FDA 510(k) Application Details - K183453

Device Classification Name	More FDA Info for this Device
510(K) Number	K183453
Device Name	VS3-IR
Applicant	Medtronic 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	12/13/2018
Decision Date	03/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review