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510(k) FDA Premarket Notification K213677

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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
00850074346227 K213677 000
00850074346098 K213677 000
00850074346081 K213677 000
00850074346074 K213677 000
00850074346067 K213677 000
00850074346050 K213677 000
00850074346043 K213677 000
00850074346036 K213677 000
00850074346029 K213677 000
00850074346012 K213677 000
00850074346104 K213677 000
00850074346111 K213677 000
00850074346128 K213677 000
00850074346210 K213677 000
00850074346203 K213677 000
00850074346197 K213677 000
00850074346180 K213677 000
00850074346173 K213677 000
00850074346166 K213677 000
00850074346159 K213677 000
00850074346142 K213677 000
00850074346135 K213677 000
00850074346005 K213677 000

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Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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