FDA 510(k) Application Details - K233892

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K233892
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Zhuhai Dipu Medical Technology Co., Ltd. 1F,Building 13,GMP Production Workshop, Zhuhai International Health Harbor, No. 628 Airport West Road, Sanzao Town Zhuhai, Jinwan District 519090 CN Other 510(k) Applications for this Company
Contact	Huan Wang 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	12/08/2023
Decision Date	06/13/2024
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