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510(k) FDA Premarket Notification K232673

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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
06932195330805 K232673 000
06932195330904 K232673 000
06932195330898 K232673 000
06932195330881 K232673 000
06932195330874 K232673 000
06932195330867 K232673 000
06932195330850 K232673 000
06932195330843 K232673 000
06932195330836 K232673 000
06932195330829 K232673 000
06932195330812 K232673 000
06932195323470 K232673 000
06932195323463 K232673 000
06932195323456 K232673 000
06932195330911 K232673 000
06932195330928 K232673 000
06932195330935 K232673 000
06932195331062 K232673 000
06932195331055 K232673 000
06932195331048 K232673 000
06932195331031 K232673 000
06932195331024 K232673 000
06932195331017 K232673 000
06932195331000 K232673 000
06932195330997 K232673 000
06932195330980 K232673 000
06932195330973 K232673 000
06932195330966 K232673 000
06932195330959 K232673 000
06932195330942 K232673 000
06932195323449 K232673 000

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Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 156
Function: _error_handler


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