FDA 510(k) Application Details - K172835

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K172835
Device Name	Insufflator, Laparoscopic
Applicant	GRI Medical and Electronic Technology Co., Ltd. 105 Honggao Road, Xiuzhou Industry Zone Jiaxing 314031 CN Other 510(k) Applications for this Company
Contact	Martin Paugh Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2017
Decision Date	06/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review