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510(k) FDA Premarket Notification K234079

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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
00810129090574 K234079 000
00810129091472 K234079 000
00810129091427 K234079 000
00810129091373 K234079 000
00810129091328 K234079 000
00810129091267 K234079 000
00810129091212 K234079 000
00810129091168 K234079 000
00810129091113 K234079 000
00810129091069 K234079 000
00810129091014 K234079 000
00810129090963 K234079 000
00810129090918 K234079 000
00810129092233 K234079 000
00810129091922 K234079 000
00810129092080 K234079 000
00810129090529 K234079 000
00810129090475 K234079 000
00810129090420 K234079 000
00810129090369 K234079 000
00810129090314 K234079 000
00810129090260 K234079 000
00810129090215 K234079 000
00810129090161 K234079 000
00810129090116 K234079 000
00810129090062 K234079 000
00810129090017 K234079 000
00810129092158 K234079 000
00810129092110 K234079 000
00810129092370 K234079 000

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Filename: fda.report/pmn_item.php

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Function: _error_handler


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