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510(k) FDA Premarket Notification H110002

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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
00850052743055 H110002 000
00856264005462 H110002 000
00856264005455 H110002 000
00856264005448 H110002 000
00856264005431 H110002 000
00856264005424 H110002 000
00856264005417 H110002 000
00856264005400 H110002 000
00856264005301 H110002 000
00856264005295 H110002 000
00856264005288 H110002 000
10856264005322 H110002 000
00856264005479 H110002 000
00856264005486 H110002 000
00856264005493 H110002 000
00856264005516 H110002 000
00856264005592 H110002 000
00856264005585 H110002 000
00856264005578 H110002 000
00856264005561 H110002 000
00856264005523 H110002 000
00856264005509 H110002 000
00850052743123 H110002 003
00850052743161 H110002 003
00850052743109 H110002 003
00850052743130 H110002 003
00856264005332 H110002 003
00856264005349 H110002 003
00856264005356 H110002 003
00856264005394 H110002 003
00856264005387 H110002 003
00856264005370 H110002 003
00856264005363 H110002 003
00850052743116 H110002 003
00856264005318 H110002 004
00856264005721 H110002 018
00856264005714 H110002 018
00856264005707 H110002 018
00856264005691 H110002 018
00850052743000 H110002 018
00856264005776 H110002 020

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