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Function: _error_handler

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Function: _error_handler

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510(k) FDA Premarket Notification K231343

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A PHP Error was encountered

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Function: _error_handler

The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Function: _error_handler

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Function: _error_handler

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Function: _error_handler

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Function: _error_handler

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Line: 111
Function: _error_handler

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Line: 112
Function: _error_handler

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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841731135599 K231343 000
00841731135803 K231343 000
00841731135810 K231343 000
00841731135827 K231343 000
00841731135834 K231343 000
00841731135841 K231343 000
00841731135858 K231343 000
00841731135865 K231343 000
00841731135872 K231343 000
00841731135889 K231343 000
00841731135896 K231343 000
00841731135902 K231343 000
00841731135919 K231343 000
00841731135926 K231343 000
00841731135933 K231343 000
00841731135940 K231343 000
00841731135957 K231343 000
00841731135964 K231343 000
00841731135797 K231343 000
00841731135780 K231343 000
00841731135773 K231343 000
00841731135605 K231343 000
00841731135612 K231343 000
00841731135629 K231343 000
00841731135636 K231343 000
00841731135643 K231343 000
00841731135650 K231343 000
00841731135667 K231343 000
00841731135674 K231343 000
00841731135681 K231343 000
00841731135698 K231343 000
00841731135704 K231343 000
00841731135711 K231343 000
00841731135728 K231343 000
00841731135735 K231343 000
00841731135742 K231343 000
00841731135759 K231343 000
00841731135766 K231343 000
00841731135971 K231343 000
00841731135988 K231343 000
00841731135995 K231343 000
00841731136213 K231343 000
00841731136220 K231343 000
00841731136237 K231343 000
00841731136244 K231343 000
00841731136251 K231343 000
00841731136268 K231343 000
00841731136275 K231343 000
00841731136282 K231343 000
00841731136305 K231343 000
00841731136329 K231343 000
00841731135209 K231343 000
00841731135520 K231343 000
00841731135148 K231343 000
00841731135155 K231343 000
00841731135162 K231343 000
00841731135186 K231343 000
00841731135537 K231343 000
00841731136206 K231343 000
00841731136190 K231343 000
00841731136183 K231343 000
00841731136008 K231343 000
00841731136015 K231343 000
00841731136022 K231343 000
00841731136039 K231343 000
00841731136053 K231343 000
00841731136060 K231343 000
00841731136077 K231343 000
00841731136084 K231343 000
00841731136091 K231343 000
00841731136107 K231343 000
00841731136114 K231343 000
00841731136121 K231343 000
00841731136138 K231343 000
00841731136145 K231343 000
00841731136152 K231343 000
00841731136169 K231343 000
00841731136176 K231343 000
00841731142528 K231343 000

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Severity: Notice

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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