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510(k) FDA Premarket Notification N980003

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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
00888912087636 N980003 000
00888912087438 N980003 000
00888912087421 N980003 000
00888912087414 N980003 000
00888912075749 N980003 000
00888912075725 N980003 000
00888912075701 N980003 000
00888912075695 N980003 000
00888912075671 N980003 000
00888912087445 N980003 000
00888912087469 N980003 000
00888912087483 N980003 000
00888912087629 N980003 000
00888912087612 N980003 000
00888912087599 N980003 000
00888912087537 N980003 000
00888912087520 N980003 000
00888912075664 N980003 000
00888912087513 N980003 000
00888912087506 N980003 000
00888912087490 N980003 000
00888912087223 N980003 007
00888912087209 N980003 007
00888912087230 N980003 007
00888912087247 N980003 007
00888912087216 N980003 007

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