510(k) K062640

STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 by Stryker Instruments — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2006
Date Received
September 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type