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510(k) FDA Premarket Notification K243042

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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
06935650603209 K243042 000
06935650603117 K243042 000
06935650603100 K243042 000
06935650603094 K243042 000
06935650603087 K243042 000
06935650603070 K243042 000
06935650603063 K243042 000
06935650603056 K243042 000
06935650603049 K243042 000
06935650602073 K243042 000
06935650602066 K243042 000
06935650602059 K243042 000
06935650603124 K243042 000
06935650603131 K243042 000
06935650603254 K243042 000
06935650603247 K243042 000
06935650603230 K243042 000
06935650603223 K243042 000
06935650603216 K243042 000
06935650603193 K243042 000
06935650603186 K243042 000
06935650603179 K243042 000
06935650603162 K243042 000
06935650603155 K243042 000
06935650603148 K243042 000
06935650602042 K243042 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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