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510(k) FDA Premarket Notification K243790

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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
10886705033317 K243790 000
10886705033072 K243790 000
10886705033065 K243790 000
10886705033058 K243790 000
10886705033041 K243790 000
10886705033034 K243790 000
10886705033027 K243790 000
10886705033010 K243790 000
10886705033003 K243790 000
10886705032990 K243790 000
10886705032983 K243790 000
10886705032976 K243790 000
10886705032969 K243790 000
10886705033089 K243790 000
10886705033096 K243790 000
10886705033300 K243790 000
10886705033201 K243790 000
10886705033195 K243790 000
10886705033188 K243790 000
10886705033171 K243790 000
10886705033164 K243790 000
10886705033157 K243790 000
10886705033140 K243790 000
10886705033133 K243790 000
10886705033126 K243790 000
10886705033119 K243790 000
10886705033102 K243790 000
10886705032952 K243790 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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