FDA 510(k) Application Details - K013215

Device Classification Name Stimulator, Nerve, Ac-Powered

  More FDA Info for this Device
510(K) Number K013215
Device Name Stimulator, Nerve, Ac-Powered
Applicant NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
Other 510(k) Applications for this Company
Contact SEAN M CURRY
Other 510(k) Applications for this Contact
Regulation Number 868.2775

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

  More FDA Info for this Product Code
Date Received 09/26/2001
Decision Date 10/16/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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