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FDA 510(k)

KOWA, FM-600, MODEL LSS50

K-Number: K091039 · 2009-08-07

ApplicantKowa Co. , Ltd.
Decision Date2009-08-07
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA, FM-600, MODEL LSS50 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Co. , Ltd.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K091039. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA, FM-600, MODEL LSS50?

KOWA, FM-600, MODEL LSS50 is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Kowa Co. , Ltd.. The 510(k) number is K091039.

When did KOWA, FM-600, MODEL LSS50 receive FDA 510(k) clearance?

KOWA, FM-600, MODEL LSS50 received FDA 510(k) clearance on 2009-08-07, under 510(k) number K091039.

Who is the listed applicant for KOWA, FM-600, MODEL LSS50?

The FDA 510(k) record lists Kowa Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOWA, FM-600, MODEL LSS50?

The FDA product code for KOWA, FM-600, MODEL LSS50 is MYC.

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Other records listing Kowa Co. , Ltd. 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.

K112330KOWA VX-20K101628KOWA NONMYD WXK091098KOWAGENESIS-DFK091683KOWA VX-10 AK083387MODIFICATION TO KOWA NONMYD ALPHA-DIIIK082767KOWA NONMYD ALPHA-DIII

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Related Devices (Code: MYC)

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.

K261255KOWA FM-600Kowa Company, Ltd. Chofu FactoryK241931OcuMet Beacon (OCUB100)Ocusciences, Inc.K243504MAIA (AHMACME001)Centervue S.P.A.K213705DRSplusCentervue S.P.A.K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A.K192113DRSplusCentervue S.P.A.

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.

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