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510(k) FDA Premarket Notification K240758

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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
06936666590651 K240758 000
16937278648799 K240758 000
16937278648782 K240758 000
16937278648775 K240758 000
16937278648768 K240758 000
16937278648751 K240758 000
16937278645194 K240758 000
16937278645187 K240758 000
16937278645170 K240758 000
16937278645163 K240758 000
16937278645156 K240758 000
16937278645149 K240758 000
16937278645132 K240758 000
16937278645125 K240758 000
16937278645118 K240758 000
16937278645101 K240758 000
16937278645095 K240758 000
16937278648805 K240758 000
16937278648812 K240758 000
16937278648829 K240758 000
16937278648980 K240758 000
16937278648973 K240758 000
16937278648966 K240758 000
16937278648959 K240758 000
16937278648942 K240758 000
16937278648935 K240758 000
16937278648928 K240758 000
16937278648911 K240758 000
16937278648904 K240758 000
16937278648898 K240758 000
16937278648881 K240758 000
16937278648874 K240758 000
16937278648867 K240758 000
16937278648850 K240758 000
16937278648843 K240758 000
16937278648836 K240758 000
16937278645088 K240758 000

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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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