FDA 510(k) Application Details - K201641

Device Classification Name	Laparoscope, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K201641
Device Name	Laparoscope, General & Plastic Surgery
Applicant	Beijing Biosis Healing Biological Technology Co., Ltd. No.6 plant west, Valley No.1 Bio-medicine Industry Park Daxing District Beijing 102600 CN Other 510(k) Applications for this Company
Contact	Jiali Zhou 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	06/16/2020
Decision Date	08/06/2020
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