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510(k) FDA Premarket Notification K223627

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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
B6785212670 K223627 000
B6785212230 K223627 000
B6785212220 K223627 000
B6785212210 K223627 000
B6785212200 K223627 000
B6785212190 K223627 000
B6785212180 K223627 000
B6785212170 K223627 000
B6785212160 K223627 000
B6785212150 K223627 000
B6785212140 K223627 000
B6785212130 K223627 000
B6785212120 K223627 000
B6785212110 K223627 000
B6785212100 K223627 000
B6785212090 K223627 000
B6785212080 K223627 000
B6785212240 K223627 000
B6785212250 K223627 000
B6785212410 K223627 000
B6785212400 K223627 000
B6785212390 K223627 000
B6785212380 K223627 000
B6785212370 K223627 000
B6785212360 K223627 000
B6785212350 K223627 000
B6785212340 K223627 000
B6785212330 K223627 000
B6785212320 K223627 000
B6785212310 K223627 000
B6785212300 K223627 000
B6785212290 K223627 000
B6785212280 K223627 000
B6785212270 K223627 000
B6785212260 K223627 000
B6785212070 K223627 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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