FDA 510(k) Application Details - K113551

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K113551
Device Name	Prosthesis, Esophageal
Applicant	TAEWOONG MEDICAL CO., LTD 400 N. WASHINGTON ST SUITE 100 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	STEPHEN RHODES 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	12/01/2011
Decision Date	02/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review