KOWA DR-1a— 510(k) K190573

Substantially Equivalent

Kowa Company , Ltd.

FDA 510(k) clearance K190573 for KOWA DR-1a, Substantially Equivalent on 2019-06-04. Applicant: Kowa Company , Ltd.. Device class: 2.

Clearance details

Applicant: Kowa Company , Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2019-03-06
Decision date: 2019-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chofu-Shi, 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.