FDA 510(k) Application Details - K193272

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K193272
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Guangzhou TK 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	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	11/26/2019
Decision Date	07/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review