FDA 510(k) Application Details - K162648

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K162648
Device Name	Insufflator, Laparoscopic
Applicant	TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. A02, PLANT B, NO. 278, HANGKONG RD, TIANJIN FREE TRADE ZONE TIANJIN 300308 CN Other 510(k) Applications for this Company
Contact	TAO FAN 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	09/22/2016
Decision Date	12/12/2016
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