FDA 510(k) Application Details - K202027

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K202027
Device Name	Arthroscope
Applicant	Taeyeon Medical Co., Ltd. 132-1 Donghwagongdan-Ro, Munmak-eup Wonju-Si 26365 KR Other 510(k) Applications for this Company
Contact	Sin-Ae Kang 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	07/22/2020
Decision Date	02/03/2021
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