KOWAGENESIS-DF— 510(k) K091098

Substantially Equivalent

Kowa Co. , Ltd.

FDA 510(k) clearance K091098 for KOWAGENESIS-DF, Substantially Equivalent on 2009-08-07. Applicant: Kowa Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Kowa Co. , Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2009-04-16
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.