FDA 510(k) Application Details - K190029

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K190029
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. No. 51 Shuishan Road, Zhonglou Economic Development Zone Changzhou 213023 CN Other 510(k) Applications for this Company
Contact	Boping Ma 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	01/07/2019
Decision Date	09/26/2019
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