FDA 510(k) Application Details - K172727

Device Classification Name	More FDA Info for this Device
510(K) Number	K172727
Device Name	Hemoclip
Applicant	Hangzhou AGS MedTech CO., Ltd Building 6, Kangxin Road No.597 Qianjiang Economic Development Area Hangzhou 311106 CN Other 510(k) Applications for this Company
Contact	Chunqi Han Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2017
Decision Date	04/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review