FDA 510(k) Application Details - K063560

Device Classification Name Stimulator, Nerve

  More FDA Info for this Device
510(K) Number K063560
Device Name Stimulator, Nerve
Applicant WR MEDICAL ELECTRONICS CO.
800 LAVANGER LANE
STOUGHTON, WI 53589 US
Other 510(k) Applications for this Company
Contact Gary Syring
Other 510(k) Applications for this Contact
Regulation Number 874.1820

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

  More FDA Info for this Product Code
Date Received 11/28/2006
Decision Date 01/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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