Synvitro Hyadase
K-Number: K200680 · 2020-07-17
ApplicantOrigio A/S, A Coopersurgical Company
Decision Date2020-07-17
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Synvitro Hyadase is a medical device manufactured by Origio A/S, A Coopersurgical Company. It received FDA 510(k) clearance on 2020-07-17 under approval number K200680. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synvitro Hyadase?
Synvitro Hyadase is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Origio A/S, A Coopersurgical Company. The 510(k) number is K200680.
When was Synvitro Hyadase approved by the FDA?
Synvitro Hyadase received FDA 510(k) clearance on 2020-07-17, under approval number K200680.
What company makes Synvitro Hyadase?
Synvitro Hyadase is manufactured by Origio A/S, A Coopersurgical Company.
What is the FDA product code for Synvitro Hyadase?
The FDA product code for Synvitro Hyadase is MQL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.