FDA 510(k) Application Details - K012883

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K012883
Device Name	Prosthesis, Esophageal
Applicant	BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 US Other 510(k) Applications for this Company
Contact	KATHLEEN MORAHAN 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	08/28/2001
Decision Date	10/12/2001
Decision	SESU - SE - WITH LIMITATIONS
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