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510(k) FDA Premarket Notification K240898

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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
00653159016950 K240898 000
00653159017063 K240898 000
00653159017070 K240898 000
00653159017087 K240898 000
00653159017094 K240898 000
00653159017100 K240898 000
00653159017117 K240898 000
00653159017124 K240898 000
00653159017131 K240898 000
00653159017056 K240898 000
00653159017049 K240898 000
00653159016967 K240898 000
00653159016974 K240898 000
00653159016981 K240898 000
00653159016998 K240898 000
00653159017001 K240898 000
00653159017018 K240898 000
00653159017025 K240898 000
00653159017032 K240898 000
00653159017148 K240898 000
00653159017155 K240898 000
00653159016875 K240898 000
00653159016882 K240898 000
00653159016899 K240898 000
00653159016905 K240898 000
00653159016912 K240898 000
00653159016929 K240898 000
00653159016936 K240898 000
00653159016943 K240898 000
00653159016868 K240898 000
00653159016851 K240898 000
00653159017162 K240898 000
00653159017179 K240898 000
00653159017186 K240898 000
00653159017193 K240898 000
00653159016806 K240898 000
00653159016820 K240898 000
00653159016837 K240898 000
00653159016844 K240898 000
00653159012709 K240898 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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