FDA 510(k) Application Details - K970121

Device Classification Name Dislodger, Stone, Flexible

  More FDA Info for this Device
510(K) Number K970121
Device Name Dislodger, Stone, Flexible
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
Other 510(k) Applications for this Company
Contact CAROL J HOLLOWAY
Other 510(k) Applications for this Contact
Regulation Number 876.4680

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

  More FDA Info for this Product Code
Date Received 01/14/1997
Decision Date 04/02/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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