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510(k) FDA Premarket Notification P140031

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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
00690103193978 P140031 000
00690103193930 P140031 000
00690103193947 P140031 000
00690103193954 P140031 000
00690103193961 P140031 000
00690103194364 P140031 000
00690103194005 P140031 000
00690103194340 P140031 000
00690103194357 P140031 000
00690103194166 P140031 024
00690103194173 P140031 024
00690103194159 P140031 024
00690103194142 P140031 024
00690103194135 P140031 024
00690103194180 P140031 024
00690103198331 P140031 035
00690103201451 P140031 074
00690103200782 P140031 074
00690103201444 P140031 074
00690103201338 P140031 074
00690103201321 P140031 074
00690103201314 P140031 074
00690103201260 P140031 074
00690103201253 P140031 074
00690103201246 P140031 074
00690103201239 P140031 074
00690103201192 P140031 074
00690103201185 P140031 074
00690103207811 P140031 091
00690103207828 P140031 091
00690103207835 P140031 091
00690103217001 P140031 141
00690103215823 P140031 141
00690103215816 P140031 141
00690103215809 P140031 141
00690103215793 P140031 141

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