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510(k) FDA Premarket Notification K251043

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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
07630542744105 K251043 000
07630542743993 K251043 000
07630542743986 K251043 000
07630542743979 K251043 000
07630542743962 K251043 000
07630542743955 K251043 000
07630542743948 K251043 000
07630542743931 K251043 000
07630345752857 K251043 000
07630542744006 K251043 000
07630542744013 K251043 000
07630542744099 K251043 000
07630542744082 K251043 000
07630542744075 K251043 000
07630542744068 K251043 000
07630542744051 K251043 000
07630542744044 K251043 000
07630542744037 K251043 000
07630542744020 K251043 000
07630345734525 K251043 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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