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510(k) FDA Premarket Notification K240900

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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
00850057445244 K240900 000
00850057445107 K240900 000
00850057445091 K240900 000
00850057445084 K240900 000
00850057445077 K240900 000
00850057445060 K240900 000
00850057445053 K240900 000
00850057445046 K240900 000
00850057445039 K240900 000
00850057445022 K240900 000
00850057445015 K240900 000
00850057445114 K240900 000
00850057445121 K240900 000
00850057445138 K240900 000
00850057445237 K240900 000
00850057445220 K240900 000
00850057445213 K240900 000
00850057445206 K240900 000
00850057445190 K240900 000
00850057445183 K240900 000
00850057445176 K240900 000
00850057445169 K240900 000
00850057445152 K240900 000
00850057445145 K240900 000
00850057445008 K240900 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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