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510(k) FDA Premarket Notification K250338

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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
07630542752209 K250338 000
07630542750748 K250338 000
07630542750731 K250338 000
07630542750724 K250338 000
07630542750717 K250338 000
07630542750700 K250338 000
07630542750694 K250338 000
07630542750472 K250338 000
07630542750465 K250338 000
07630542750458 K250338 000
07630542750441 K250338 000
07630542750434 K250338 000
07630542750427 K250338 000
07630542750410 K250338 000
07630542750403 K250338 000
07630542750397 K250338 000
07630542750380 K250338 000
07630542750755 K250338 000
07630542750762 K250338 000
07630542751165 K250338 000
07630542751158 K250338 000
07630542751141 K250338 000
07630542751134 K250338 000
07630542751127 K250338 000
07630542751110 K250338 000
07630542751103 K250338 000
07630542751097 K250338 000
07630542751080 K250338 000
07630542751073 K250338 000
07630542751066 K250338 000
07630542751011 K250338 000
07630542750809 K250338 000
07630542750793 K250338 000
07630542750786 K250338 000
07630542750779 K250338 000
07630542750373 K250338 000

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Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

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Line: 156
Function: _error_handler


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