BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Baha BIA300 Implants with Abutments

    Reg #: 3014579188 · FEI: 3014579188 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Cochlear Americas Warehouse
    Registration Number
    3014579188
    FEI Number
    3014579188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7101 S. Fulton St., Suite E
    City
    Centennial
    State
    CO
    ZIP
    80112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100360

    Owner / Operator

    Firm Name
    COCHLEAR AMERICAS
    Operator Number
    9076254
    Address
    10350 Park Meadows Drive
    City
    Lone Tree
    State
    CO
    Postal Code
    80124
    Country
    US
    Correspondent
    Laura - Blair

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    Baha BIA300 Implants with Abutments

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198