FDA 510(k) Application Details - K182287

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K182287
Device Name	Arthroscope
Applicant	Imedicom Co., Ltd. #612, 172, LS-ro Gunpo-si 435824 KR Other 510(k) Applications for this Company
Contact	Bonggu Ha 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	08/23/2018
Decision Date	04/06/2019
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