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510(k) FDA Premarket Notification K250167

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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
00195860027035 K250167 000
00195860026687 K250167 000
00195860026670 K250167 000
00195860026663 K250167 000
00195860026656 K250167 000
00195860026649 K250167 000
00195860026632 K250167 000
00195860026625 K250167 000
00195860026618 K250167 000
00195860026601 K250167 000
00195860026595 K250167 000
00195860026588 K250167 000
00195860026571 K250167 000
00195860026694 K250167 000
00195860026700 K250167 000
00195860026717 K250167 000
00195860027028 K250167 000
00195860026878 K250167 000
00195860026816 K250167 000
00195860026809 K250167 000
00195860026793 K250167 000
00195860026786 K250167 000
00195860026779 K250167 000
00195860026762 K250167 000
00195860026755 K250167 000
00195860026748 K250167 000
00195860026731 K250167 000
00195860026724 K250167 000
00195860026564 K250167 000

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Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 156
Function: _error_handler


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