FDA 510(k) Application Details - K193339

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K193339
Device Name	Insufflator, Laparoscopic
Applicant	Guangzhou T.K Medical Instrument Co., Ltd. A601, Guangzhou International Business Incubator, Guangzhou Science Park Guangzhou 510663 CN Other 510(k) Applications for this Company
Contact	Tracy Weng 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	12/02/2019
Decision Date	01/30/2020
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