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510(k) FDA Premarket Notification K241128

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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
08800043936418 K241128 000
08800043936272 K241128 000
08800043936265 K241128 000
08800043936258 K241128 000
08800043936241 K241128 000
08800043936234 K241128 000
08800043936227 K241128 000
08800043936210 K241128 000
08800043936203 K241128 000
08800043936197 K241128 000
08800043936180 K241128 000
08800043936173 K241128 000
08800043936289 K241128 000
08800043936296 K241128 000
08800043936401 K241128 000
08800043936395 K241128 000
08800043936388 K241128 000
08800043936371 K241128 000
08800043936364 K241128 000
08800043936357 K241128 000
08800043936340 K241128 000
08800043936333 K241128 000
08800043936326 K241128 000
08800043936319 K241128 000
08800043936302 K241128 000
08800043936166 K241128 000

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