BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Extender Cable M00546750

    Reg #: 1450997 · FEI: 1450997 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Northgate Technologies Inc.
    Registration Number
    1450997
    FEI Number
    1450997
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1591 Scottsdale Court
    City
    Elgin
    State
    IL
    ZIP
    60123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130368

    Owner / Operator

    Firm Name
    Northgate Technologies, Inc.
    Operator Number
    10092614
    Address
    1591 Scottsdale Court
    City
    Elgin
    State
    IL
    Postal Code
    60123
    Country
    US
    Correspondent
    Todd Gatto

    Products

    Device Name Product Code
    Lithotriptor, Electro-Hydraulic FFK

    Proprietary Names

    Extender Cable M00546750 Autolith Touch 9-202-00 Autolith Touch 375cm Probe 9-202-3751 Autolith Uro-Touch 120cm Probe 9-203-1203 Autolith Uro-Touch 9-203-00 Autolith Touch 375cm Probe 9-202-3751DS Extender Cable 9-004-00 Autolith Touch 250cm Probe 9-202-2501 Autolith Touch 1.9FR 375cm DS Probe M00546620 Autolith Touch M005466800

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device