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510(k) FDA Premarket Notification K223927

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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
B432360CASSET00110 K223927 000
B432360CAS00250 K223927 000
B432360CAS00040 K223927 000
B432360CASSET00220 K223927 000
B432360CAS01420 K223927 000
B432360CAS01260 K223927 000
B432360CASSET00290 K223927 000
B432360CASSET00280 K223927 000
B432360CASSET00230 K223927 000
B432360CAS2200 K223927 000
B432360CAS01470 K223927 000
B432360CAS00260 K223927 000
B432360CAS00280 K223927 000
B432360CAS01250 K223927 000
B432360CAS01230 K223927 000
B432360CAS01200 K223927 000
B432360CAS01130 K223927 000
B432360CAS01100 K223927 000
B432360CAS01090 K223927 000
B432360CAS01080 K223927 000
B432360CAS01070 K223927 000
B432360CAS01060 K223927 000
B432360CAS01050 K223927 000
B432360CAS01450 K223927 000

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