LEKSELL SURGIPLAN WITH IMAGEMERGE

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 Surgiplan With Imagemerge.

Pre-market Notification Details

Device IDK033340
510k NumberK033340
Device Name:LEKSELL SURGIPLAN WITH IMAGEMERGE
ClassificationNeurological Stereotaxic Instrument
Applicant ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 PO BOX 7593 Stockholm,  SE Se-103 93
ContactPeter Lowendahl
CorrespondentPeter Lowendahl
ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 PO BOX 7593 Stockholm,  SE Se-103 93
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-17
Decision Date2004-02-12

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