KOWA KT-800— 510(k) K053444

Substantially Equivalent

Kowa Co. , Ltd.

FDA 510(k) clearance K053444 for KOWA KT-800, Substantially Equivalent on 2006-06-09. Applicant: Kowa Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Kowa Co. , Ltd.
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2005-12-09
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mie-Ken, JP

Download summary PDF View on FDA.gov ↗

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