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510(k) FDA Premarket Notification K243478

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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
07899878063285 K243478 000
07630031740755 K243478 000
07630031740748 K243478 000
07630031727923 K243478 000
07630031727916 K243478 000
07630031727909 K243478 000
07630031727893 K243478 000
07630031727886 K243478 000
07630031727879 K243478 000
07630031727862 K243478 000
07630031740786 K243478 000
07630031740793 K243478 000
07630031755308 K243478 000
07899878063278 K243478 000
07899878063261 K243478 000
07899878063254 K243478 000
07899878063247 K243478 000
07630031755353 K243478 000
07630031755346 K243478 000
07630031755339 K243478 000
07630031755322 K243478 000
07630031755315 K243478 000
07630031727848 K243478 000

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Filename: fda.report/pmn_item.php

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