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510(k) FDA Premarket Notification K250622

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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
05055662970784 K250622 000
05055662970876 K250622 000
05055662970869 K250622 000
05055662970852 K250622 000
05055662970845 K250622 000
05055662970838 K250622 000
05055662970821 K250622 000
05055662970814 K250622 000
05055662970791 K250622 000
05055662970760 K250622 000
05055662970753 K250622 000
05055662970746 K250622 000
05055662970685 K250622 000
05055662970647 K250622 000
05055662970593 K250622 000
05055662970500 K250622 000
05055662970494 K250622 000
05055662970470 K250622 000
05055662970883 K250622 000
05055662970906 K250622 000
05055662970913 K250622 000
05055662970777 K250622 000
05055662970739 K250622 000
05055662970722 K250622 000
05055662970715 K250622 000
05055662970708 K250622 000
05055662970692 K250622 000
05055662971064 K250622 000
05055662971019 K250622 000
05055662971002 K250622 000
05055662970999 K250622 000
05055662970982 K250622 000
05055662970975 K250622 000
05055662970968 K250622 000
05055662970951 K250622 000
05055662970944 K250622 000
05055662970937 K250622 000
05055662970920 K250622 000
05055662970463 K250622 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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