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510(k) FDA Premarket Notification K250477

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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
07630542784873 K250477 000
07630542741395 K250477 000
07630542741388 K250477 000
07630542741371 K250477 000
07630542739613 K250477 000
07630542739606 K250477 000
07630542739590 K250477 000
07630542739583 K250477 000
07630542735394 K250477 000
07630542735387 K250477 000
07630542735370 K250477 000
07630542741401 K250477 000
07630542741418 K250477 000
07630542784866 K250477 000
07630542784859 K250477 000
07630542741890 K250477 000
07630542741876 K250477 000
07630542741869 K250477 000
07630542741692 K250477 000
07630542741685 K250477 000
07630542741678 K250477 000
07630542741661 K250477 000
07630542741425 K250477 000
07630542735363 K250477 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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