FDA 510(k) Application Details - K201342

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K201342
Device Name	Prosthesis, Tracheal, Expandable
Applicant	M.I. Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si 17706 KR Other 510(k) Applications for this Company
Contact	Inae Kim Other 510(k) Applications for this Contact
Regulation Number	878.3720   More FDA Info for this Regulation Number
Classification Product Code	JCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2020
Decision Date	12/31/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review