LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT

Neurological Stereotaxic Instrument

ELEKTA INSTRUMENT AB

The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Image Guidance Surgical System, View Scope, Surgiscope,elekta Insight.

Pre-market Notification Details

Device IDK992882
510k NumberK992882
Device Name:LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
ClassificationNeurological Stereotaxic Instrument
Applicant ELEKTA INSTRUMENT AB 21911 ERIE LN. Lake Forest,  CA  92630
ContactCarol Patterson
CorrespondentCarol Patterson
ELEKTA INSTRUMENT AB 21911 ERIE LN. Lake Forest,  CA  92630
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-26
Decision Date1999-09-24
Summary:summary

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