BEUDAMED
    FDA Registration Active 🇫🇷 France

    Suprascan Delivery System

    Reg #: 9680671 · FEI: 3003465293 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QUANTEL MEDICAL
    Registration Number
    9680671
    FEI Number
    3003465293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 rue du bois Joli, CS40015
    City
    COURNON AUVERGNE Puy-de-Dome
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K100678

    Owner / Operator

    Firm Name
    QUANTEL MEDICAL
    Operator Number
    9002489
    Address
    1 Rue de Bois Joli, CS 40015
    City
    Cournon d’Auvergne, Cedex
    State
    FR-NOTA
    Postal Code
    63808
    Country
    FR
    Correspondent
    Bruno - Pages

    US Agent

    Business Name
    OConnell Regulatory Consultants, Inc.
    Contact Name
    Maureen OConnell
    Address
    44 Oak Street
    City
    Stoneham
    State
    MA
    ZIP
    02180
    Country
    US
    Email
    [email protected]
    Phone
    978 2071245

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Suprascan Delivery System

    Establishment Types

    Manufacture Medical Device