BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kowa Pharmaceuticals America, Inc.

    Reg #: 2080939 · FEI: 2080939 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Kowa Pharmaceuticals America, Inc.
    Registration Number
    2080939
    FEI Number
    2080939
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    530 Industrial Park Blvd
    City
    Montgomery
    State
    AL
    ZIP
    36117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960924

    Owner / Operator

    Firm Name
    Kowa Pharmaceuticals America, Inc.
    Operator Number
    2080939
    Address
    530 Industrial Park Bvld., --
    City
    Montgomery
    State
    AL
    Postal Code
    36117
    Country
    US
    Correspondent
    BENJAMIN RHODES

    Products

    Device Name Product Code
    Tonometer, Manual HKY
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Camera, Ophthalmic, Ac-Powered HKI

    Proprietary Names

    KOWA APPLANATION TONOMETER HA-1; KOWA APPLANATION TONOMETER HA-2 SL-19 KOWA DR-1a

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198