STEALTHSTATION SYSTEM

Neurological Stereotaxic Instrument

SURGICAL NAVIGATION TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Navigation Technologies, Inc. with the FDA for Stealthstation System.

Pre-market Notification Details

Device IDK974187
510k NumberK974187
Device Name:STEALTHSTATION SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield,  CO  80020
ContactRoger N White
CorrespondentRoger N White
SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield,  CO  80020
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-12
Decision Date1998-01-21
Summary:summary

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