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510(k) FDA Premarket Notification K241470

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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
00810022403204 K241470 000
00810022403068 K241470 000
00810022403099 K241470 000
00810022403105 K241470 000
00810022403129 K241470 000
00810022403136 K241470 000
00810022403143 K241470 000
00810022403150 K241470 000
00810022403167 K241470 000
00810022403174 K241470 000
00810022403181 K241470 000
00810022403198 K241470 000
00810022403051 K241470 000

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