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510(k) FDA Premarket Notification K221048

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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
EPIS18100PF0 K221048 000
EPIS33729PF0 K221048 000
EPIS34120PF0 K221048 000
EPIS34125PF0 K221048 000
EPIS34129PF0 K221048 000
EPIS37320PF0 K221048 000
EPIS37325PF0 K221048 000
EPIS37329PF0 K221048 000
EPIS51117PF0 K221048 000
EPIS51120PF0 K221048 000
EPIS51125PF0 K221048 000
EPIS52117PF0 K221048 000
EPIS33725PF0 K221048 000
EPIS33720PF0 K221048 000
EPIS33429PF0 K221048 000
EPIS31120PF0 K221048 000
EPIS31125PF0 K221048 000
EPIS31129PF0 K221048 000
EPIS32120PF0 K221048 000
EPIS32125PF0 K221048 000
EPIS32129PF0 K221048 000
EPIS33120PF0 K221048 000
EPIS33125PF0 K221048 000
EPIS33129PF0 K221048 000
EPIS33420PF0 K221048 000
EPIS33425PF0 K221048 000
EPIS52120PF0 K221048 000
EPIS52125PF0 K221048 000
EPIS53117PF0 K221048 000
EPIS61120PF0 K221048 000
EPIS61125PF0 K221048 000
EPIS62120PF0 K221048 000
EPIS62125PF0 K221048 000
EPIS63420PF0 K221048 000
EPIS63425PF0 K221048 000
EPIS63720PF0 K221048 000
EPIS63725PF0 K221048 000
EPIS64120PF0 K221048 000
EPIS64125PF0 K221048 000
EPIS67320PF0 K221048 000
EPIS57325PF0 K221048 000
EPIS57320PF0 K221048 000
EPIS57317PF0 K221048 000
EPIS53120PF0 K221048 000
EPIS53125PF0 K221048 000
EPIS53417PF0 K221048 000
EPIS53420PF0 K221048 000
EPIS53425PF0 K221048 000
EPIS53717PF0 K221048 000
EPIS53720PF0 K221048 000
EPIS53725PF0 K221048 000
EPIS54117PF0 K221048 000
EPIS54120PF0 K221048 000
EPIS54125PF0 K221048 000
EPIS67325PF0 K221048 000

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