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510(k) FDA Premarket Notification K211812

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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
08809822765508 K211812 000
08809728995429 K211812 000
08809728995412 K211812 000
08809728995405 K211812 000
08809728995399 K211812 000
08809728995382 K211812 000
08809728995375 K211812 000
08809728995351 K211812 000
08809728995344 K211812 000
08809728995337 K211812 000
08809728995320 K211812 000
08809728995313 K211812 000
08809728995443 K211812 000
08809728995450 K211812 000
08809822765492 K211812 000
08809728995566 K211812 000
08809728995559 K211812 000
08809728995542 K211812 000
08809728995535 K211812 000
08809728995528 K211812 000
08809728995511 K211812 000
08809728995498 K211812 000
08809728995481 K211812 000
08809728995474 K211812 000
08809728995467 K211812 000
08809728994699 K211812 000

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Filename: fda.report/pmn_item.php

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Backtrace:

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Line: 156
Function: _error_handler


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