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510(k) FDA Premarket Notification K243671

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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
00193982623036 K243671 000
00193982622725 K243671 000
00193982622701 K243671 000
00193982622695 K243671 000
00193982622671 K243671 000
00193982622664 K243671 000
00193982622640 K243671 000
00193982622633 K243671 000
00193982622619 K243671 000
00193982622602 K243671 000
00193982622589 K243671 000
00193982622572 K243671 000
00193982622558 K243671 000
00193982622541 K243671 000
00193982622527 K243671 000
00193982622381 K243671 000
00193982622732 K243671 000
00193982622756 K243671 000
00193982623029 K243671 000
00193982623012 K243671 000
00193982622992 K243671 000
00193982622985 K243671 000
00193982622978 K243671 000
00193982622961 K243671 000
00193982622954 K243671 000
00193982622930 K243671 000
00193982622923 K243671 000
00193982622909 K243671 000
00193982622886 K243671 000
00193982622879 K243671 000
00193982622824 K243671 000
00193982622817 K243671 000
00193982622763 K243671 000
00193982622374 K243671 000

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