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510(k) FDA Premarket Notification K242458

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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
D818137968 K242458 000
D818137882 K242458 000
D818137877 K242458 000
D818137874 K242458 000
D818137866 K242458 000
D818137865 K242458 000
D818137864 K242458 000
D818137861 K242458 000
D818137860 K242458 000
D818137859 K242458 000
D818137851 K242458 000
D818137850 K242458 000
D818137849 K242458 000
D818137841 K242458 000
D818137840 K242458 000
D818137885 K242458 000
D818137890 K242458 000
D818137965 K242458 000
D818137959 K242458 000
D818137953 K242458 000
D818137945 K242458 000
D818137942 K242458 000
D818137936 K242458 000
D818137930 K242458 000
D818137922 K242458 000
D818137918 K242458 000
D818137910 K242458 000
D818137902 K242458 000
D818137897 K242458 000
D818137894 K242458 000
D818137893 K242458 000
D818137839 K242458 000

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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