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510(k) FDA Premarket Notification K243308

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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
07640187462753 K243308 000
07640187462623 K243308 000
07640187462630 K243308 000
07640187462647 K243308 000
07640187462654 K243308 000
07640187462661 K243308 000
07640187462678 K243308 000
07640187462685 K243308 000
07640187462692 K243308 000
07640187462708 K243308 000
07640187462715 K243308 000
07640187462722 K243308 000
07640187462739 K243308 000
07640187462746 K243308 000
07640187462616 K243308 000

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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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