BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Otomag Alpha (M) Magnetic Implant

    Reg #: 3010376846 · FEI: 3010376846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSYPKA MEDTEC INC.
    Registration Number
    3010376846
    FEI Number
    3010376846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1804 Skyway Dr Unit E
    City
    Longmont
    State
    CO
    ZIP
    80504
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153391

    Owner / Operator

    Firm Name
    Osypka Medtec Inc.
    Operator Number
    10044669
    Address
    1804 Skyway Dr. Unit E
    City
    Longmont
    State
    CO
    Postal Code
    80504
    Country
    US
    Correspondent
    Dana D Tompkins

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    Otomag Alpha (M) Magnetic Implant

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device