FDA 510(k) Application Details - K980113

Device Classification Name	Stent,Metallic,Expandable,Duodenal   More FDA Info for this Device
510(K) Number	K980113
Device Name	Stent,Metallic,Expandable,Duodenal
Applicant	BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. MINNEAPOLIS, MN 55442 US Other 510(k) Applications for this Company
Contact	Kathy Jo Fahey Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	MUM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/1998
Decision Date	04/03/1998
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