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510(k) FDA Premarket Notification K250602

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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
00850041805856 K250602 000
00850041805573 K250602 000
00850041805597 K250602 000
00850041805603 K250602 000
00850041805627 K250602 000
00850041805634 K250602 000
00850041805641 K250602 000
00850041805658 K250602 000
00850041805672 K250602 000
00850041805566 K250602 000
00850041805504 K250602 000
00850041805580 K250602 000
00850041805610 K250602 000
00850041805665 K250602 000
00850041805689 K250602 000
00850041805696 K250602 000
00850041805467 K250602 000
00850041805474 K250602 000
00850041805481 K250602 000
00850041805702 K250602 000
00850041805719 K250602 000
00850041805825 K250602 000
00850041805832 K250602 000
00850041805849 K250602 000
00810166521673 K250602 000
00850041805498 K250602 000
00850041805511 K250602 000
00850041805528 K250602 000
00850041805535 K250602 000
00850041805818 K250602 000
00850041805801 K250602 000
00850041805726 K250602 000
00850041805733 K250602 000
00850041805740 K250602 000
00850041805757 K250602 000
00850041805764 K250602 000
00850041805771 K250602 000
00850041805788 K250602 000
00850041805795 K250602 000
00850041805559 K250602 000

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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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