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510(k) FDA Premarket Notification K232013

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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
04543660025830 K232013 000
04543660025724 K232013 000
04543660025717 K232013 000
04543660025700 K232013 000
04543660025694 K232013 000
04543660025632 K232013 000
04543660025625 K232013 000
04543660025618 K232013 000
04543660025601 K232013 000
04543660025731 K232013 000
04543660025748 K232013 000
04543660025823 K232013 000
04543660025816 K232013 000
04543660025809 K232013 000
04543660025793 K232013 000
04543660025786 K232013 000
04543660025779 K232013 000
04543660025762 K232013 000
04543660025755 K232013 000
04543660025595 K232013 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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