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510(k) FDA Premarket Notification P010038

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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
00858012005007 P010038 012
00858012005830 P010038 013
00858012005823 P010038 013
00858012005809 P010038 013
00858012005175 P010038 013
00858012005168 P010038 013
00858012005151 P010038 013
00858012005144 P010038 013
00858012005137 P010038 013
00858012005120 P010038 013
00858012005113 P010038 013
00858012005106 P010038 013
00858012005847 P010038 013
00858012005861 P010038 013
00858012005014 P010038 013
00858012005854 P010038 013
00858012005816 P010038 013
00858012005793 P010038 013
00858012005601 P010038 013
00858012005083 P010038 013
00858012005076 P010038 013
00858012005052 P010038 013
00858012005038 P010038 013
00858012005021 P010038 013
00858012005090 P010038 013
00858012005069 P010038 016
00858012005045 P010038 017

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