FDA 510(k) Application Details - K972008

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

  More FDA Info for this Device
510(K) Number K972008
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant EUROPEAN SURGICAL, INC.
73 EAGLES NEST RD.
DUXBURY, MA 02332 US
Other 510(k) Applications for this Company
Contact ELLEN HENKE-KNUPP
Other 510(k) Applications for this Contact
Regulation Number 878.4400

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

  More FDA Info for this Product Code
Date Received 05/30/1997
Decision Date 09/19/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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