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510(k) FDA Premarket Notification K240684

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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
06936415987978 K240684 000
06936415980771 K240684 000
06936415980764 K240684 000
06936415980757 K240684 000
06936415980740 K240684 000
06936415980733 K240684 000
06936415980726 K240684 000
06903053044066 K240684 000
06903053044059 K240684 000
06903053044042 K240684 000
06903053044035 K240684 000
06936415980788 K240684 000
06936415980795 K240684 000
06936415986216 K240684 000
06936415986209 K240684 000
06936415980870 K240684 000
06936415980863 K240684 000
06936415980856 K240684 000
06936415980849 K240684 000
06936415980832 K240684 000
06936415980825 K240684 000
06936415980818 K240684 000
06936415980801 K240684 000
06903053044028 K240684 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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