FDA 510(k) Application Details - K102275

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

  More FDA Info for this Device
510(K) Number K102275
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant THERMEDX, LLC
31200 SOLON ROAD
UNIT 1
SOLON, OH 44139 US
Other 510(k) Applications for this Company
Contact JOHN R SCOVILLE
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 08/11/2010
Decision Date 03/25/2011
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