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510(k) FDA Premarket Notification P160048

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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
00817491021908 P160048 000
00817491020819 P160048 000
00817491020826 P160048 000
00817491021328 P160048 000
00817491021304 P160048 000
00817491021311 P160048 000
00817491021335 P160048 000
00817491021397 P160048 000
00817491021403 P160048 000
00817491022493 P160048 000
00817491021458 P160048 000
00817491021441 P160048 000
00817491021434 P160048 000
00817491021427 P160048 000
00817491021410 P160048 000
00817491022370 P160048 006
00817491022523 P160048 006
00817491022516 P160048 006
00817491023605 P160048 006
00817491023612 P160048 006
00817491022387 P160048 006
00817491022349 P160048 008
00817491022363 P160048 008
00817491022356 P160048 008
00817491023858 P160048 016
00817491022882 P160048 016
00817491022905 P160048 016
00817491022912 P160048 016
00817491022929 P160048 016
00817491022936 P160048 016
00817491022950 P160048 016
00817491022967 P160048 016
00817491022974 P160048 016
00817491021342 P160048 016
00817491023063 P160048 016
00817491023520 P160048 016
00817491023537 P160048 016
00817491023841 P160048 016

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