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510(k) FDA Premarket Notification H180002

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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
07290107982979 H180002 001
07290107982863 H180002 001
07290107982849 H180002 001
07290107982832 H180002 001
07290107982825 H180002 001
07290107982801 H180002 001
07290107982788 H180002 001
07290107982771 H180002 001
07290107982764 H180002 001
07290107982740 H180002 001
07290107982726 H180002 001
07290107982719 H180002 001
07290107982702 H180002 001
07290107984300 H180002 001
07290107984294 H180002 001
07290107984287 H180002 001
07290107982696 H180002 001
07290107982757 H180002 001
07290107982962 H180002 001
07290107982931 H180002 001
07290107982924 H180002 001
07290107982894 H180002 001
07290107982887 H180002 001
07290107982856 H180002 001
07290107982795 H180002 001
07290107982733 H180002 001
07290107982986 H180002 001
07290107982955 H180002 001
07290107982948 H180002 001
07290107982917 H180002 001
07290107982900 H180002 001
07290107982870 H180002 001
07290107982818 H180002 001
07290107984270 H180002 001

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