FDA 510(k) Application Details - K010993

Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

  More FDA Info for this Device
510(K) Number K010993
Device Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
Other 510(k) Applications for this Company
Contact LIAS M QUAGLIA
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 04/03/2001
Decision Date 04/30/2001
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