Labware, Assisted Reproduction


The following data is part of a premarket notification filed by Origio A/s with the FDA for Vitriguard.

Pre-market Notification Details

Device IDK200815
510k NumberK200815
Device Name:VitriGuard
ClassificationLabware, Assisted Reproduction
Applicant ORIGIO A/s Knardrupvej 2 Malov,  DK 2760
ContactChristine Kupchick
CorrespondentChristine Kupchick
CooperSurgical, Inc. 95 Corporate Drive Trumbull,  CT  06611
Product CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-06-25

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