FDA 510(k) Application Details - K180208

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K180208
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Fengh Medical Co., Ltd. D3 No. 6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin 214437 CN Other 510(k) Applications for this Company
Contact	Jun Zhou 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	01/24/2018
Decision Date	04/09/2018
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