FDA 510(k) Application Details - K161421

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K161421
Device Name	Laparoscope, General & Plastic Surgery
Applicant	JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. NO.99, FURONGZHONGSAN RD, XISHAN ECONOMICAL DEVELOPMENT ZONE WUXI 214000 CN Other 510(k) Applications for this Company
Contact	Vivian Sun 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	05/23/2016
Decision Date	06/24/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review