FDA 510(k) Application Details - K183675

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K183675
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Scivita Medical Technology Co., Ltd No.8, Zhong Tian Xiang, Suzhou Industrial Park Suzhou 215000 CN Other 510(k) Applications for this Company
Contact	Ruqin Wu 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	12/28/2018
Decision Date	09/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review