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510(k) FDA Premarket Notification K242559

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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
00850070544153 K242559 000
00850039704970 K242559 000
00850039704987 K242559 000
00850039704994 K242559 000
00850070544085 K242559 000
00850070544092 K242559 000
00850070544108 K242559 000
00850070544115 K242559 000
00850070544122 K242559 000
00850070544139 K242559 000
00850070544146 K242559 000
00850039704963 K242559 000

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