FDA 510(k) Application Details - K041648

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K041648
Device Name	Prosthesis, Esophageal
Applicant	TAEWOONG MEDICAL CO., LTD 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	JAMES HARVY KNAUSS 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	06/17/2004
Decision Date	04/28/2005
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