FDA 510(k) Application Details - K162197

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K162197
Device Name	Laparoscope, General & Plastic Surgery
Applicant	EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street Suzhou Industrial Park SuZhou 215000 CN Other 510(k) Applications for this Company
Contact	Hendry Zhang Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2016
Decision Date	01/18/2017
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