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510(k) FDA Premarket Notification K250316

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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
00810184540397 K250316 000
00810184540083 K250316 000
00810184540076 K250316 000
00810184540069 K250316 000
00810184540052 K250316 000
00810184540045 K250316 000
00810184540038 K250316 000
00810184540021 K250316 000
00810184540014 K250316 000
00810184540090 K250316 000
00810184540304 K250316 000
00810184540380 K250316 000
00810184540373 K250316 000
00810184540366 K250316 000
00810184540359 K250316 000
00810184540342 K250316 000
00810184540335 K250316 000
00810184540328 K250316 000
00810184540311 K250316 000
00810184540007 K250316 000

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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