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510(k) FDA Premarket Notification H170001

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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
07290018128312 H170001 000
07290018128299 H170001 000
07290018128107 H170001 000
07290018128114 H170001 000
07290018128121 H170001 000
07290018128138 H170001 000
07290018128152 H170001 000
07290018128169 H170001 000
07290018128176 H170001 000
07290018128091 H170001 000
07290018128084 H170001 000
07290018128060 H170001 000
07290018128053 H170001 000
07290018128008 H170001 002
07290018128015 H170001 002
07290018128022 H170001 002
07290018128145 H170001 002
07290018128039 H170001 002
07290018128046 H170001 002
07290018128077 H170001 002
07290018128183 H170001 002
07290018128190 H170001 002
07290018128206 H170001 002
07290018128367 H170001 002
07290018128350 H170001 002
07290018128343 H170001 002
07290018128336 H170001 002
07290018128329 H170001 002
07290018128305 H170001 002
07290018128282 H170001 002
07290018128275 H170001 002
07290018128213 H170001 002
07290018128220 H170001 002
07290018128237 H170001 002
07290018128244 H170001 002
07290018128251 H170001 002
07290018128268 H170001 002
07290018128374 H170001 003
07290018128381 H170001 003
07290018128411 H170001 003
07290014993808 H170001 007
07290018128398 H170001 010
07290018128404 H170001 010

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