FDA 510(k) Application Details - K080962

Device Classification Name Light, Surgical, Fiberoptic

  More FDA Info for this Device
510(K) Number K080962
Device Name Light, Surgical, Fiberoptic
Applicant THOMPSON SURGICAL INSTRUMENTS, INC.
10170 EAST CHERRY BEND ROAD
TRAVERSE CITY, MI 49684 US
Other 510(k) Applications for this Company
Contact STEPHANIE A ZALUCHA
Other 510(k) Applications for this Contact
Regulation Number 878.4580

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

  More FDA Info for this Product Code
Date Received 04/04/2008
Decision Date 06/25/2008
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