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510(k) FDA Premarket Notification K243907

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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
00887868140006 K243907 000
00887868139857 K243907 000
00887868139840 K243907 000
00887868139833 K243907 000
00887868139826 K243907 000
00887868139819 K243907 000
00887868139802 K243907 000
00887868139796 K243907 000
00887868139789 K243907 000
00887868139772 K243907 000
00887868139765 K243907 000
00887868139758 K243907 000
00887868139864 K243907 000
00887868139871 K243907 000
00887868139888 K243907 000
00887868139994 K243907 000
00887868139987 K243907 000
00887868139970 K243907 000
00887868139963 K243907 000
00887868139956 K243907 000
00887868139949 K243907 000
00887868139932 K243907 000
00887868139925 K243907 000
00887868139918 K243907 000
00887868139901 K243907 000
00887868139895 K243907 000
00887868139741 K243907 000

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Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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