FDA 510(k) Application Details - K223709

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K223709
Device Name	Arthroscope
Applicant	Jiangsu Changmei Medtech Co., Ltd. No.27, Xinke West Road, Luoyang Town Wujin District Changzhou 213104 CN Other 510(k) Applications for this Company
Contact	Yang Lifan Other 510(k) Applications for this Contact
Regulation Number	888.1100   More FDA Info for this Regulation Number
Classification Product Code	HRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2022
Decision Date	08/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review