FDA 510(k) Application Details - K221482

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K221482
Device Name	Prosthesis, Esophageal
Applicant	Taewoong Medical Co., Ltd. 14 Gojeong-Ro, Wolgot-Myeon Gimpo-Si 10022 KR Other 510(k) Applications for this Company
Contact	Jangsoo Lee Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2022
Decision Date	06/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review