MODIFICATION TO KOWA NONMYD ALPHA-DIII— 510(k) K083387

Substantially Equivalent

Kowa Co. , Ltd.

FDA 510(k) clearance K083387 for MODIFICATION TO KOWA NONMYD ALPHA-DIII, Substantially Equivalent on 2009-01-16. Applicant: Kowa Co. , Ltd..

Clearance details

Applicant: Kowa Co. , Ltd.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2008-11-17
Decision date: 2009-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Chuo-Ku, Tokyo, JP

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