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510(k) FDA Premarket Notification K250473

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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
00810021437781 K250473 000
00810021435565 K250473 000
00810021436876 K250473 000
00810021436883 K250473 000
00810021436937 K250473 000
00810021436944 K250473 000
00810021437019 K250473 000
00810021437026 K250473 000
00810021437033 K250473 000
00810021437040 K250473 000
00810021437057 K250473 000
00810021437064 K250473 000
00810021437156 K250473 000
00810021437163 K250473 000
00810021437545 K250473 000

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