KOWA nonmyd 8— 510(k) K191945

Substantially Equivalent

Kowa Company , Ltd.

FDA 510(k) clearance K191945 for KOWA nonmyd 8, Substantially Equivalent on 2019-09-10. Applicant: Kowa Company , Ltd..

Clearance details

Applicant: Kowa Company , Ltd.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2019-07-22
Decision date: 2019-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chofu-Shi, JP

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