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510(k) FDA Premarket Notification K241070

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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
05037881167046 K241070 000
05037881166667 K241070 000
05037881166674 K241070 000
05037881166681 K241070 000
05037881166698 K241070 000
05037881166711 K241070 000
05037881166728 K241070 000
05037881166735 K241070 000
05037881166742 K241070 000
05037881166650 K241070 000
05037881166643 K241070 000
05037881166520 K241070 000
05037881166537 K241070 000
05037881166544 K241070 000
05037881166551 K241070 000
05037881166605 K241070 000
05037881166612 K241070 000
05037881166629 K241070 000
05037881166636 K241070 000
05037881166780 K241070 000
05037881166797 K241070 000
05037881166926 K241070 000
05037881166933 K241070 000
05037881166940 K241070 000
05037881166971 K241070 000
05037881166995 K241070 000
05037881167008 K241070 000
05037881167022 K241070 000
05037881167039 K241070 000
05037881166902 K241070 000
05037881166896 K241070 000
05037881166803 K241070 000
05037881166810 K241070 000
05037881166834 K241070 000
05037881166841 K241070 000
05037881166858 K241070 000
05037881166865 K241070 000
05037881166872 K241070 000
05037881166889 K241070 000
05037881166063 K241070 000

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Filename: fda.report/pmn_item.php

Line Number: 156

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Line: 156
Function: _error_handler


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