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510(k) FDA Premarket Notification K250215

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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
09321502078962 K250215 000
09321502075527 K250215 000
09321502075510 K250215 000
09321502074858 K250215 000
09321502074841 K250215 000
09321502074834 K250215 000
09321502074827 K250215 000
09321502074810 K250215 000
09321502074803 K250215 000
09321502074797 K250215 000
09321502074780 K250215 000
09321502074773 K250215 000
09321502074766 K250215 000
09321502074759 K250215 000
09321502074742 K250215 000
09321502074735 K250215 000
09321502074728 K250215 000
09321502074711 K250215 000
09321502078443 K250215 000
09321502078450 K250215 000
09321502078467 K250215 000
09321502078955 K250215 000
09321502078948 K250215 000
09321502078627 K250215 000
09321502078603 K250215 000
09321502078597 K250215 000
09321502078580 K250215 000
09321502078573 K250215 000
09321502078566 K250215 000
09321502078559 K250215 000
09321502078542 K250215 000
09321502078535 K250215 000
09321502078528 K250215 000
09321502078511 K250215 000
09321502078504 K250215 000
09321502078498 K250215 000
09321502078481 K250215 000
09321502078474 K250215 000
09321502074704 K250215 000

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Line: 156
Function: _error_handler


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