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510(k) FDA Premarket Notification K241467

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Function: _error_handler

The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

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Line: 111
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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B6785235150 K241467 000
B6785235390 K241467 000
B678523538S0 K241467 000
B6785235380 K241467 000
B678523537S0 K241467 000
B6785235370 K241467 000
B678523536S0 K241467 000
B6785235360 K241467 000
B678523535S0 K241467 000
B678523539S0 K241467 000
B6785235500 K241467 000
B6785235540 K241467 000
B678523553S0 K241467 000
B6785235530 K241467 000
B678523552S0 K241467 000
B6785235520 K241467 000
B678523551S0 K241467 000
B6785235510 K241467 000
B678523550S0 K241467 000
B6785235350 K241467 000
B678523534S0 K241467 000
B6785235190 K241467 000
B678523518S0 K241467 000
B6785235180 K241467 000
B678523517S0 K241467 000
B6785235170 K241467 000
B678523516S0 K241467 000
B6785235160 K241467 000
B678523515S0 K241467 000
B678523519S0 K241467 000
B6785235300 K241467 000
B6785235340 K241467 000
B678523533S0 K241467 000
B6785235330 K241467 000
B678523532S0 K241467 000
B6785235320 K241467 000
B678523531S0 K241467 000
B6785235310 K241467 000
B678523530S0 K241467 000
B678523554S0 K241467 000
B6785235200 K241467 000
B6785235440 K241467 000
B678523543S0 K241467 000
B6785235430 K241467 000
B678523542S0 K241467 000
B6785235420 K241467 000
B678523541S0 K241467 000
B6785235410 K241467 000
B678523540S0 K241467 000
B678523544S0 K241467 000
B6785235450 K241467 000
B6785235490 K241467 000
B678523548S0 K241467 000
B6785235480 K241467 000
B678523547S0 K241467 000
B6785235470 K241467 000
B678523546S0 K241467 000
B6785235460 K241467 000
B678523545S0 K241467 000
B6785235400 K241467 000
B678523529S0 K241467 000
B6785235240 K241467 000
B678523523S0 K241467 000
B6785235230 K241467 000
B678523522S0 K241467 000
B6785235220 K241467 000
B678523521S0 K241467 000
B6785235210 K241467 000
B678523520S0 K241467 000
B678523524S0 K241467 000
B6785235250 K241467 000
B6785235290 K241467 000
B678523528S0 K241467 000
B6785235280 K241467 000
B678523527S0 K241467 000
B6785235270 K241467 000
B678523526S0 K241467 000
B6785235260 K241467 000
B678523525S0 K241467 000
B678523549S0 K241467 000

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Severity: Notice

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Filename: fda.report/pmn_item.php

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Backtrace:

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Line: 156
Function: _error_handler


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