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510(k) FDA Premarket Notification K243357

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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
08809986461728 K243357 000
08809986466266 K243357 000
08809986466259 K243357 000
08809986466242 K243357 000
08809986466235 K243357 000
08809986466228 K243357 000
08809986466211 K243357 000
08809986466204 K243357 000
08809986466198 K243357 000
08809986466181 K243357 000
08809986466174 K243357 000
08809986466167 K243357 000
08809986466273 K243357 000
08809986466280 K243357 000
08809986461711 K243357 000
08809986461704 K243357 000
08809986461698 K243357 000
08809986461681 K243357 000
08809986461186 K243357 000
08809986461179 K243357 000
08809986461162 K243357 000
08809986461155 K243357 000
08809986461148 K243357 000
08809986461131 K243357 000
08809986461124 K243357 000
08809986466150 K243357 000

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Line Number: 156

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Line: 156
Function: _error_handler


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