FDA 510(k) Application Details - K110833

Device Classification Name Duodenoscope And Accessories, Flexible/Rigid

  More FDA Info for this Device
510(K) Number K110833
Device Name Duodenoscope And Accessories, Flexible/Rigid
Applicant Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact JANIS TARANTO
Other 510(k) Applications for this Contact
Regulation Number 876.1500

  More FDA Info for this Regulation Number
Classification Product Code FDT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/25/2011
Decision Date 04/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact