Decision Date2020-03-04
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lubrina 2 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2020-03-04 under 510(k) 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. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K190509.
When did Lubrina 2 receive FDA 510(k) clearance?
Lubrina 2 received FDA 510(k) clearance on 2020-03-04, under 510(k) number K190509.
Who is the listed applicant for Lubrina 2?
The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lubrina 2?
The FDA product code for Lubrina 2 is EFB.
Other records listing J. Morita USA, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: EFB)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.