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510(k) FDA Premarket Notification K223858

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The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E30819945210 K223858 000
E308199352110 K223858 000
E308199352120 K223858 000
E308199441100 K223858 000
E308199442100 K223858 000
E308199451100 K223858 000
E308199452100 K223858 000
E30819935212 K223858 000
E30819935111 K223858 000
E30819935211 K223858 000
E30819944110 K223858 000
E30819944210 K223858 000
E30819945110 K223858 000
E308199351110 K223858 000

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