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510(k) FDA Premarket Notification K230891

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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
08903837093868 K230891 000
08903837404855 K230891 000
08903837404862 K230891 000
08903837404879 K230891 000
08903837404893 K230891 000
08903837404909 K230891 000
08903837404916 K230891 000
08903837404923 K230891 000
08903837562517 K230891 000
08903837562524 K230891 000
08903837093806 K230891 000
08903837093820 K230891 000
08903837093844 K230891 000
08903837404848 K230891 000

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