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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 16 Results
ProductCode: HAW Applicant: ELEKTA INSTRUMENT AB Decision Date To: 05/21/2024
 
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leksell vantage stereotactic system Elekta Instrument AB K190887 08/01/2019
leksell vantage stereotactic system Elekta Instrument AB K171123 09/15/2017
leksell stereotactic system, injection/ aspiration needle kit ELEKTA INSTRUMENT AB K152558 03/02/2016
leksell stereotactic system with reusable fixation screws ELEKTA INSTRUMENT AB K080355 05/01/2009
leksell surgiplan, model 1006947 ELEKTA INSTRUMENT AB K080250 05/13/2008
elekta esarte frame system ELEKTA INSTRUMENT AB K051746 07/25/2005
elekta microdrive, model 916716 ELEKTA INSTRUMENT AB K040979 07/23/2004
leksell surgiplan with imagemerge ELEKTA INSTRUMENT AB K033340 02/12/2004
elekta leksell stereotactic system with mr post kit ELEKTA INSTRUMENT AB K031999 07/25/2003
modification to leksell stereotactic system ELEKTA INSTRUMENT AB K031980 07/25/2003
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