KOWA, FM-600, MODEL LSS50— 510(k) K091039

Substantially Equivalent

Kowa Co. , Ltd.

FDA 510(k) clearance K091039 for KOWA, FM-600, MODEL LSS50, Substantially Equivalent on 2009-08-07. Applicant: Kowa Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Kowa Co. , Ltd.
Product code: Code MYC
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2009-04-13
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuo-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

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