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510(k) FDA Premarket Notification K243784

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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
07613327101164 K243784 000
07613327021653 K243784 000
07613327021561 K243784 000
07613327021554 K243784 000
07613327021530 K243784 000
07613327021523 K243784 000
07613327021516 K243784 000
04546540035820 K243784 000
04546540035813 K243784 000
04546540035806 K243784 000
04546540035790 K243784 000
07613327021660 K243784 000
07613327021691 K243784 000
07613327022803 K243784 000
07613327022988 K243784 000
07613327022971 K243784 000
07613327022964 K243784 000
07613327022957 K243784 000
07613327022933 K243784 000
07613327022926 K243784 000
07613327022865 K243784 000
07613327022858 K243784 000
07613327022827 K243784 000
07613327022810 K243784 000
04546540035714 K243784 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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