FDA 510(k) Application Details - K970717

Device Classification Name Electrode, Electrosurgical, Active, Urological

  More FDA Info for this Device
510(K) Number K970717
Device Name Electrode, Electrosurgical, Active, Urological
Applicant NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN, IL 60123 US
Other 510(k) Applications for this Company
Contact CASEY KUREK
Other 510(k) Applications for this Contact
Regulation Number 876.4300

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

  More FDA Info for this Product Code
Date Received 02/27/1997
Decision Date 05/08/1997
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