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510(k) FDA Premarket Notification K230242

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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
00810118210181 K230242 000
00810118210358 K230242 000
00810118210341 K230242 000
00810118210334 K230242 000
00810118210327 K230242 000
00810118210310 K230242 000
00810118210303 K230242 000
00810118210297 K230242 000
00810118210280 K230242 000
00810118210273 K230242 000
00810118210266 K230242 000
00810118210259 K230242 000
00810118210242 K230242 000
00810118210235 K230242 000
00810118210228 K230242 000
00810118210211 K230242 000
00810118210204 K230242 000
00810118210365 K230242 000
00810118210006 K230242 000
00810118210013 K230242 000
00810118210174 K230242 000
00810118210167 K230242 000
00810118210150 K230242 000
00810118210143 K230242 000
00810118210136 K230242 000
00810118210129 K230242 000
00810118210112 K230242 000
00810118210105 K230242 000
00810118210099 K230242 000
00810118210082 K230242 000
00810118210075 K230242 000
00810118210068 K230242 000
00810118210051 K230242 000
00810118210044 K230242 000
00810118210037 K230242 000
00810118210020 K230242 000
00810118210198 K230242 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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