FDA 510(k) Application Details - K152001

Device Classification Name	More FDA Info for this Device
510(K) Number	K152001
Device Name	Sterile Repositionable Hemostasis Clipping Device
Applicant	Micro-Tech (Nanjing) CO.,Ltd. No. 10 Gaoke Third Road Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Becky Li 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	07/20/2015
Decision Date	12/10/2015
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