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510(k) FDA Premarket Notification K222469

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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
06009544040873 K222469 000
06009544047926 K222469 000
06009544047919 K222469 000
06009544047902 K222469 000
06009544047896 K222469 000
06009544047889 K222469 000
06009544047872 K222469 000
06009544047865 K222469 000
06009544047858 K222469 000
06009544047841 K222469 000
06009544047834 K222469 000
06009544047827 K222469 000
06009544047933 K222469 000
06009544047940 K222469 000
06009544047957 K222469 000
06009544040866 K222469 000
06009544040859 K222469 000
06009544040835 K222469 000
06009544040828 K222469 000
06009544040811 K222469 000
06009544048572 K222469 000
06009544048008 K222469 000
06009544047995 K222469 000
06009544047988 K222469 000
06009544047971 K222469 000
06009544047964 K222469 000
06009544047810 K222469 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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