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510(k) FDA Premarket Notification K252623

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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
00889024686762 K252623 000
00889024686595 K252623 000
00889024686588 K252623 000
00889024686571 K252623 000
00889024686564 K252623 000
00889024686557 K252623 000
00889024686540 K252623 000
00889024686533 K252623 000
00889024686526 K252623 000
00889024686519 K252623 000
00889024686502 K252623 000
00889024686496 K252623 000
00889024683945 K252623 000
00889024683938 K252623 000
00889024686601 K252623 000
00889024686618 K252623 000
00889024686625 K252623 000
00889024686755 K252623 000
00889024686748 K252623 000
00889024686731 K252623 000
00889024686724 K252623 000
00889024686717 K252623 000
00889024686700 K252623 000
00889024686694 K252623 000
00889024686687 K252623 000
00889024686670 K252623 000
00889024686663 K252623 000
00889024686656 K252623 000
00889024686649 K252623 000
00889024686632 K252623 000
00889024683884 K252623 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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