FDA 510(k) Application Details - K023424

Device Classification Name Neurological Stereotaxic Instrument

  More FDA Info for this Device
510(K) Number K023424
Device Name Neurological Stereotaxic Instrument
Applicant DENX ADVANCED DENTAL SYSTEMS
MIZPE AVIV, INDUSTRIAL PARK 13
M.P. MISGAV 20187 IL
Other 510(k) Applications for this Company
Contact KOBY BEN-BARAK
Other 510(k) Applications for this Contact
Regulation Number 882.4560

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

  More FDA Info for this Product Code
Date Received 10/11/2002
Decision Date 05/09/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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