Lubrina 2
K-Number: K190509 · 2020-03-04
ApplicantJ. Morita USA, Inc.
Decision Date2020-03-04
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lubrina 2 is a medical device manufactured by J. Morita USA, Inc.. It received FDA 510(k) clearance on 2020-03-04 under approval number K190509. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lubrina 2?
Lubrina 2 is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by J. Morita USA, Inc.. The 510(k) number is K190509.
When was Lubrina 2 approved by the FDA?
Lubrina 2 received FDA 510(k) clearance on 2020-03-04, under approval number K190509.
What company makes Lubrina 2?
Lubrina 2 is manufactured by J. Morita USA, Inc..
What is the FDA product code for Lubrina 2?
The FDA product code for Lubrina 2 is EFB.
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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.