FDA 510(k) Application Details - K150068

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K150068
Device Name	Insufflator, Laparoscopic
Applicant	Unimicro Medical Systems (ShenZhen) Co.,Ltd. 2/F, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Weizhong Chen 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	01/13/2015
Decision Date	07/31/2015
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