FDA 510(k) Application Details - K172358

Device Classification Name	Device, Thermal, Hemorrhoids   More FDA Info for this Device
510(K) Number	K172358
Device Name	Device, Thermal, Hemorrhoids
Applicant	Privi Medical Pte Ltd 79 Ayer Rajah Crescent #05-03 Singapore 139955 SG Other 510(k) Applications for this Company
Contact	Prusothman M Sinha Raja Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2017
Decision Date	01/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review