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510(k) FDA Premarket Notification K202356

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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
08938531860249 K202356 000
08938531860119 K202356 000
08938531860102 K202356 000
08938531860096 K202356 000
08938531860089 K202356 000
08938531860072 K202356 000
08938531860065 K202356 000
08938531860058 K202356 000
08938531860041 K202356 000
08938531860034 K202356 000
08938531860027 K202356 000
08938531860126 K202356 000
08938531860133 K202356 000
08938531860232 K202356 000
08938531860225 K202356 000
08938531860218 K202356 000
08938531860201 K202356 000
08938531860195 K202356 000
08938531860188 K202356 000
08938531860171 K202356 000
08938531860164 K202356 000
08938531860157 K202356 000
08938531860140 K202356 000
08938531860010 K202356 000

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Line Number: 156

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Line: 156
Function: _error_handler


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