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510(k) FDA Premarket Notification K233375

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A PHP Error was encountered

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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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Function: _error_handler

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Function: _error_handler

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Function: _error_handler

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Function: _error_handler

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Function: _error_handler

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Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B678523439S0 K233375 000
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B678523381S0 K233375 000
B678523380S0 K233375 000
B678523379S0 K233375 000
B678523378S0 K233375 000
B678523391S0 K233375 000
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B678523393S0 K233375 000
B678523406S0 K233375 000
B678523405S0 K233375 000
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B678523399S0 K233375 000
B678523398S0 K233375 000
B678523397S0 K233375 000
B678523396S0 K233375 000
B678523395S0 K233375 000
B678523394S0 K233375 000
B678523377S0 K233375 000
B678523440S0 K233375 000
B678523506S0 K233375 000
B678523486S0 K233375 000
B678523485S0 K233375 000
B678523484S0 K233375 000
B678523483S0 K233375 000
B678523482S0 K233375 000
B678523481S0 K233375 000
B678523480S0 K233375 000
B678523479S0 K233375 000
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B678523477S0 K233375 000
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B678523489S0 K233375 000
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B678523504S0 K233375 000
B678523503S0 K233375 000
B678523501S0 K233375 000
B678523500S0 K233375 000
B678523499S0 K233375 000
B678523498S0 K233375 000
B678523496S0 K233375 000
B678523495S0 K233375 000
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B678523491S0 K233375 000
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B678523473S0 K233375 000
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B678523454S0 K233375 000
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B678523461S0 K233375 000
B678523460S0 K233375 000
B678523459S0 K233375 000
B678523458S0 K233375 000
B678523441S0 K233375 000

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Backtrace:

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Line: 156
Function: _error_handler


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