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510(k) FDA Premarket Notification K220059

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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
06973471960613 K220059 000
06973471968763 K220059 000
06973471968503 K220059 000
06973471968510 K220059 000
06973471968527 K220059 000
06973471960507 K220059 000
06973471960514 K220059 000
06973471960521 K220059 000
06973471960545 K220059 000
06973471960552 K220059 000
06973471960569 K220059 000
06973471960576 K220059 000
06973471960583 K220059 000
06973471960590 K220059 000
06973471960606 K220059 000
26973471968781 K220059 000

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