STEALTHSTATION WITH FLUOROMERGE SOFTWARE

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 With Fluoromerge Software.

Pre-market Notification Details

Device IDK020338
510k NumberK020338
Device Name:STEALTHSTATION WITH FLUOROMERGE SOFTWARE
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 COAL CREEK CIR. Louisville,  CO  80027
ContactVictoria G Rendon
CorrespondentVictoria G Rendon
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 826 COAL CREEK CIR. Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-01
Decision Date2002-02-27
Summary:summary

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