FDA 510(k) Application Details - K152703

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

  More FDA Info for this Device
510(K) Number K152703
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MEDTRONIC ADVANCED ENERGY
180 INTERNATIONAL DRIVE
PORTSMOUTH, NH 03801 US
Other 510(k) Applications for this Company
Contact LYDIA SAKAKEENY
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 09/21/2015
Decision Date 07/08/2016
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