Synvitro Hyadase

Media, Reproductive

Origio A/s, A CooperSurgical Company

The following data is part of a premarket notification filed by Origio A/s, A Coopersurgical Company with the FDA for Synvitro Hyadase.

Pre-market Notification Details

Device IDK200680
510k NumberK200680
Device Name:Synvitro Hyadase
ClassificationMedia, Reproductive
Applicant Origio A/s, A CooperSurgical Company Knardrupvej 2 Malov,  DK 2760
ContactMonika Bak
CorrespondentMonika Bak
Origio A/s, A CooperSurgical Company Knardrupvej 2 Malov,  DK 2760
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2020-07-17

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