FDA 510(k) Application Details - K992946

Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)

  More FDA Info for this Device
510(K) Number K992946
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant ADVANCED NEUROMODULATION SYSTEMS
6501 WINDCREST DRIVE SUITE 100
PLANO, TX 75024 US
Other 510(k) Applications for this Company
Contact KATRYNA WARREN
Other 510(k) Applications for this Contact
Regulation Number 882.5880

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

  More FDA Info for this Product Code
Date Received 09/01/1999
Decision Date 09/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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