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510(k) FDA Premarket Notification K221806

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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
00190837169411 K221806 000
00190837153502 K221806 000
00190837153496 K221806 000
00190837153489 K221806 000
00190837153472 K221806 000
00190837153465 K221806 000
00190837153458 K221806 000
00190837153441 K221806 000
00190837153434 K221806 000
00190837153427 K221806 000
00190837153403 K221806 000
00190837153397 K221806 000
00190837153380 K221806 000
00190837153373 K221806 000
00190837153366 K221806 000
00190837153519 K221806 000
00190837153533 K221806 000
00190837153540 K221806 000
00190837169428 K221806 000
00190837153410 K221806 000
00190837153663 K221806 000
00190837153656 K221806 000
00190837153649 K221806 000
00190837153632 K221806 000
00190837153625 K221806 000
00190837153618 K221806 000
00190837153601 K221806 000
00190837153595 K221806 000
00190837153588 K221806 000
00190837153571 K221806 000
00190837153564 K221806 000
00190837153557 K221806 000
00190837153359 K221806 000

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Filename: fda.report/pmn_item.php

Line Number: 156

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Line: 156
Function: _error_handler


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