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510(k) FDA Premarket Notification K241484

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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
B058AS50681 K241484 000
B058AHN08225R1 K241484 000
B058AHN08225L1 K241484 000
B058AHN08210R1 K241484 000
B058AHN08210L1 K241484 000
B058AHN08180R1 K241484 000
B058AHN08180L1 K241484 000
B058AHN11C10L1 K241484 000
B058AHN11C05L1 K241484 000
B058AHN08240L1 K241484 000
B058AHN08240R1 K241484 000
B058AS50401 K241484 000
B058AS50641 K241484 000
B058AS50601 K241484 000
B058AS50561 K241484 000
B058AS50521 K241484 000
B058AS50481 K241484 000
B058AS50461 K241484 000
B058AS50441 K241484 000
B058AS50421 K241484 000
B058AHN11C00L1 K241484 000

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