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510(k) FDA Premarket Notification K243265

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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
00810131882754 K243265 000
00810131881252 K243265 000
00810131881726 K243265 000
00810131881801 K243265 000
00810131881818 K243265 000
00810131881825 K243265 000
00810131881832 K243265 000
00810131881856 K243265 000
00810131881986 K243265 000
00810131882051 K243265 000
00810131882068 K243265 000
00810131882075 K243265 000
00810131882174 K243265 000
00810131882402 K243265 000
00810131882419 K243265 000
00810131882426 K243265 000
00810131882723 K243265 000
00810131882747 K243265 000
00810131880330 K243265 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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