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510(k) FDA Premarket Notification K250209

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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
06954414670462 K250209 000
06954414670271 K250209 000
06954414670264 K250209 000
06954414670257 K250209 000
06954414670240 K250209 000
06954414670233 K250209 000
06954414670226 K250209 000
06954414670219 K250209 000
06954414670202 K250209 000
06954414670196 K250209 000
06954414670189 K250209 000
06954414670172 K250209 000
06954414670165 K250209 000
06954414670158 K250209 000
06954414670141 K250209 000
06954414670134 K250209 000
06954414670127 K250209 000
06954414670288 K250209 000
06954414670295 K250209 000
06954414670455 K250209 000
06954414670448 K250209 000
06954414670431 K250209 000
06954414670424 K250209 000
06954414670417 K250209 000
06954414670400 K250209 000
06954414670394 K250209 000
06954414670387 K250209 000
06954414670370 K250209 000
06954414670363 K250209 000
06954414670356 K250209 000
06954414670349 K250209 000
06954414670332 K250209 000
06954414670325 K250209 000
06954414670318 K250209 000
06954414670301 K250209 000
06954414670110 K250209 000

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Filename: fda.report/pmn_item.php

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Line: 156
Function: _error_handler


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