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510(k) FDA Premarket Notification K253511

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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
00763000936907 K253511 000
00763000936730 K253511 000
00763000936723 K253511 000
00763000936716 K253511 000
00763000936709 K253511 000
00763000936693 K253511 000
00763000936686 K253511 000
00763000936679 K253511 000
00763000936662 K253511 000
00763000936655 K253511 000
00763000936648 K253511 000
00763000936631 K253511 000
00763000936624 K253511 000
00763000936617 K253511 000
00763000936600 K253511 000
00763000936747 K253511 000
00763000936754 K253511 000
00763000936891 K253511 000
00763000936884 K253511 000
00763000936877 K253511 000
00763000936860 K253511 000
00763000936853 K253511 000
00763000936846 K253511 000
00763000936839 K253511 000
00763000936822 K253511 000
00763000936815 K253511 000
00763000936808 K253511 000
00763000936792 K253511 000
00763000936785 K253511 000
00763000936778 K253511 000
00763000936761 K253511 000
00763000936594 K253511 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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