KOWA SL-17— 510(k) K133755

Substantially Equivalent

Kowa Co. , Ltd.

FDA 510(k) clearance K133755 for KOWA SL-17, Substantially Equivalent on 2014-03-11. Applicant: Kowa Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Kowa Co. , Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2013-12-09
Decision date: 2014-03-11
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.