FDA 510(k) Application Details - K013025

Device Classification Name Neurological Stereotaxic Instrument

  More FDA Info for this Device
510(K) Number K013025
Device Name Neurological Stereotaxic Instrument
Applicant Z-KAT, INC.
2903 SIMMS ST.
HOLLYWOOD, FL 33020 US
Other 510(k) Applications for this Company
Contact WILLIAM F TAPIA
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 09/10/2001
Decision Date 10/03/2001
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