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510(k) FDA Premarket Notification K214009

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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
06923533809695 K214009 000
06923533809213 K214009 000
06923533809183 K214009 000
06923533809121 K214009 000
06923533808971 K214009 000
06923533808940 K214009 000
06923533808735 K214009 000
06923533808704 K214009 000
06923533808490 K214009 000
06923533808469 K214009 000
06923533808407 K214009 000
06923533809367 K214009 000
06923533809428 K214009 000
06923533809510 K214009 000
06923533808889 K214009 000
06923533808643 K214009 000
06923533808636 K214009 000
06923533808391 K214009 000
06923533808155 K214009 000
06923533808162 K214009 000
06923533809725 K214009 000
06923533809664 K214009 000
06923533809572 K214009 000
06923533808223 K214009 000

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Line Number: 156

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