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510(k) FDA Premarket Notification K213815

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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
B387VGSJT3222400 K213815 000
B387VGSJT4216250 K213815 000
B387VGSJT4216300 K213815 000
B387VGSJT4216350 K213815 000
B387VGSJT4216400 K213815 000
B387VGSJT4216500 K213815 000
B387VGSJT4222200 K213815 000
B387VGSJT4222250 K213815 000
B387VGSJT4222300 K213815 000
B387VGSJT4222350 K213815 000
B387VGSJT4222400 K213815 000
B387VGSJT422240750 K213815 000
B387VGSJT4222500 K213815 000
B387VGSJT3216200 K213815 000
B387VGSJT3216300 K213815 000
B387VGSJT3222200 K213815 000
B387VGSJT4216200 K213815 000

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