FDA 510(k) Application Details - K071063

Device Classification Name Tracking, Soft Tissue, Intraoperative

  More FDA Info for this Device
510(K) Number K071063
Device Name Tracking, Soft Tissue, Intraoperative
Applicant PATHFINDER THERAPEUTICS, INC.
2969 ARMORY DRIVE
SUITE 100A
NASHVILLE, TN 37204 US
Other 510(k) Applications for this Company
Contact JAMES D STEFANSIC
Other 510(k) Applications for this Contact
Regulation Number 882.4560

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

  More FDA Info for this Product Code
Date Received 04/16/2007
Decision Date 12/20/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
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