FDA 510(k) Application Details - K080782

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K080782
Device Name	Prosthesis, Esophageal
Applicant	TAEWOONG MEDICAL CO., LTD 5536 TROWBRIDGE DRIVE DUNWOODY, GA 30338 US Other 510(k) Applications for this Company
Contact	CATHRYN N CAMBRIA 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	03/19/2008
Decision Date	01/30/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review