Medical Device Manufacturer · JP , Chofu-Shi

Kowa Company , Ltd.

3 submissions · 3 cleared · Since 2019
3
Total
3
Cleared
0
Denied

Kowa Company , Ltd. — FDA 510(k) Submissions

Kowa Company , Ltd. has submitted 3 FDA 510(k) premarket notifications since 2019, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Camera, Ophthalmic, Ac-powered, Biomicroscope, Slit-lamp, Ac-powered . Use the specialty filter in the sidebar to narrow results.

3 devices
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All3 Ophthalmic 3