FDA 510(k) Application Details - K022648

Device Classification Name Tubes, Gastrointestinal (And Accessories)

  More FDA Info for this Device
510(K) Number K022648
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
Other 510(k) Applications for this Company
Contact PAIGE SWEENEY
Other 510(k) Applications for this Contact
Regulation Number 876.5980

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

  More FDA Info for this Product Code
Date Received 08/09/2002
Decision Date 09/05/2002
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