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510(k) FDA Premarket Notification K233508

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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
00810055524112 K233508 000
00810055523931 K233508 000
00810055523924 K233508 000
00810055523917 K233508 000
00810055523900 K233508 000
00810055523894 K233508 000
00810055523887 K233508 000
00810055523870 K233508 000
00810055523863 K233508 000
00810055523856 K233508 000
00810055523849 K233508 000
00810055523832 K233508 000
00810055523825 K233508 000
00810055523818 K233508 000
00810055523801 K233508 000
00810055523795 K233508 000
00810055523948 K233508 000
00810055523955 K233508 000
00810055524105 K233508 000
00810055524099 K233508 000
00810055524082 K233508 000
00810055524075 K233508 000
00810055524068 K233508 000
00810055524051 K233508 000
00810055524044 K233508 000
00810055524037 K233508 000
00810055524020 K233508 000
00810055524013 K233508 000
00810055524006 K233508 000
00810055523993 K233508 000
00810055523986 K233508 000
00810055523979 K233508 000
00810055523962 K233508 000
00810055523788 K233508 000

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