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510(k) FDA Premarket Notification K242816

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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
00810111543316 K242816 000
10810111543139 K242816 000
10810111543122 K242816 000
10810111543115 K242816 000
10810111543108 K242816 000
10810111543092 K242816 000
10810111543085 K242816 000
10810111543078 K242816 000
10810111543061 K242816 000
10810111543054 K242816 000
10810111543047 K242816 000
10810111543030 K242816 000
10810111543023 K242816 000
10810111543016 K242816 000
10810111543009 K242816 000
10810111543146 K242816 000
10810111543153 K242816 000
10810111543160 K242816 000
00810111543309 K242816 000
00810111543293 K242816 000
00810111543286 K242816 000
10810111543276 K242816 000
10810111543269 K242816 000
10810111543252 K242816 000
10810111543245 K242816 000
10810111543238 K242816 000
10810111543221 K242816 000
10810111543214 K242816 000
10810111543207 K242816 000
10810111543191 K242816 000
10810111543184 K242816 000
10810111543177 K242816 000
10810111542996 K242816 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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