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510(k) FDA Premarket Notification K231280

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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
07290117350904 K231280 000
17290109336005 K231280 000
17290109335992 K231280 000
17290109335985 K231280 000
17290109335978 K231280 000
17290109335947 K231280 000
17290109335930 K231280 000
17290109335923 K231280 000
17290109335916 K231280 000
17290109335909 K231280 000
27290109335890 K231280 000
17290109335886 K231280 000
17290109335879 K231280 000
17290109335862 K231280 000
17290109336012 K231280 000
17290109336029 K231280 000
07290117350843 K231280 000
07290117350836 K231280 000
07290117350805 K231280 000
07290117350782 K231280 000
07290117350881 K231280 000
07290117350874 K231280 000
07290117350867 K231280 000
07290117350799 K231280 000
07290117351291 K231280 000
17290117351243 K231280 000
17290109336050 K231280 000
17290109336043 K231280 000
17290109336036 K231280 000
07290117351345 K231280 000

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