FDA 510(k) Application Details - K052425

Device Classification Name Neurological Stereotaxic Instrument

  More FDA Info for this Device
510(K) Number K052425
Device Name Neurological Stereotaxic Instrument
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
Contact STEPHEN H MCKELVEY
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 09/02/2005
Decision Date 12/28/2005
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