BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Baumrucker Bipolar PK Working Element; Iglesias Bipolar PK Working Element; PK Front Load Working Elements

    Reg #: 1519132 · FEI: 1519132 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Nissha Medical Technologies (Ohio), Inc.
    Registration Number
    1519132
    FEI Number
    1519132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    93 NORTH PLEASANT ST.
    City
    Norwalk
    State
    OH
    ZIP
    44857
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021166

    Owner / Operator

    Firm Name
    Nissha Medical Technologies
    Operator Number
    9106359
    Address
    400 EXCHANGE STREET, --
    City
    Buffalo
    State
    NY
    Postal Code
    14204
    Country
    US
    Correspondent
    Jessica Potter

    Products

    Device Name Product Code
    Cystourethroscope FBO
    Resectoscope, Working Element FDC

    Proprietary Names

    Baumrucker Bipolar PK Working Element; Iglesias Bipolar PK Working Element; PK Front Load Working Elements

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)