STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE

Neurological Stereotaxic Instrument

MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES

The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Stealthstation System Advanced Contour Registration Software Module.

Pre-market Notification Details

Device IDK030106
510k NumberK030106
Device Name:STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 Coal Creek Circle Louisville,  CO  80027
ContactVictoria G Rendon
CorrespondentVictoria G Rendon
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 Coal Creek Circle Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-13
Decision Date2003-02-12
Summary:summary

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