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510(k) FDA Premarket Notification K220179

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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
06974267891272 K220179 000
06974267890343 K220179 000
06974267890336 K220179 000
06974267890299 K220179 000
06974267890282 K220179 000
06974267890268 K220179 000
06974267890244 K220179 000
06974267890176 K220179 000
06974267890152 K220179 000
06974267890138 K220179 000
06974267890961 K220179 000
06974267891258 K220179 000
06974267891265 K220179 000
06974267891388 K220179 000
06974267891364 K220179 000
06974267891357 K220179 000
06974267891340 K220179 000
06974267891326 K220179 000
06974267891319 K220179 000
06974267891302 K220179 000
06974267891296 K220179 000
06974267891289 K220179 000
06974267890039 K220179 000

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Filename: fda.report/pmn_item.php

Line Number: 156

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