STEALTHSTATION TREATMENT GUIDANCE PLATFORM

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 Treatment Guidance Platform.

Pre-market Notification Details

Device IDK992927
510k NumberK992927
Device Name:STEALTHSTATION TREATMENT GUIDANCE PLATFORM
ClassificationNeurological Stereotaxic Instrument
Applicant SURGICAL NAVIGATION TECHNOLOGIES, INC. 530 COMPTON ST. Broomfield,  CO  80020
ContactAngelique Destruel
CorrespondentAngelique Destruel
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 Received1999-08-31
Decision Date1999-12-29
Summary:summary

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