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510(k) FDA Premarket Notification K230143

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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
08435457279945 K230143 000
08435457279761 K230143 000
08435457279754 K230143 000
08435457279747 K230143 000
08435457279730 K230143 000
08435457279723 K230143 000
08435457279716 K230143 000
08435457279709 K230143 000
08435457279693 K230143 000
08435457279686 K230143 000
08435457279679 K230143 000
08435457279662 K230143 000
08435457279655 K230143 000
08435457279648 K230143 000
08435457279631 K230143 000
08435457279624 K230143 000
08435457279778 K230143 000
08435457279785 K230143 000
08435457279938 K230143 000
08435457279921 K230143 000
08435457279914 K230143 000
08435457279907 K230143 000
08435457279891 K230143 000
08435457279884 K230143 000
08435457279877 K230143 000
08435457279860 K230143 000
08435457279853 K230143 000
08435457279846 K230143 000
08435457279839 K230143 000
08435457279822 K230143 000
08435457279815 K230143 000
08435457279808 K230143 000
08435457279792 K230143 000
08435457279617 K230143 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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