SELF ADHERING NAVIGUS GUIDE

Neurological Stereotaxic Instrument

IMAGE-GUIDED NEUROLOGICS, INC.

The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Self Adhering Navigus Guide.

Pre-market Notification Details

Device IDK001192
510k NumberK001192
Device Name:SELF ADHERING NAVIGUS GUIDE
ClassificationNeurological Stereotaxic Instrument
Applicant IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne,  FL  32935
ContactDavid M Lee
CorrespondentDavid M Lee
IMAGE-GUIDED NEUROLOGICS, INC. 2290 W. EAU GALLIE BLVD. SUITE 210 Melbourne,  FL  32935
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-12
Decision Date2000-06-07

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