BEUDAMED
    FDA Registration Active 🇫🇷 France

    Satelec Newtron P5 XS

    Reg #: 8044015 · FEI: 3004536551 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SATELEC-ACTEON GROUP
    Registration Number
    8044015
    FEI Number
    3004536551
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Z.I. DU PHARE, 17, AVENUE GUSTAVE EIFFEL
    City
    MERIGNAC Gironde
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K132322

    Owner / Operator

    Firm Name
    SATELEC-ACTEON GROUP
    Operator Number
    9004992
    Address
    124 Gaither Drive, Suite 140
    City
    Mount Laurel
    State
    NJ
    Postal Code
    08054
    Country
    US
    Correspondent
    Noelle Zuccarello

    US Agent

    Business Name
    SATELEC - ACTEON, INC.
    Contact Name
    Noelle Zuccarello
    Address
    124 GAITHER DR., SUITE 140
    City
    MOUNT LAUREL
    State
    NJ
    ZIP
    08054
    Country
    US
    Email
    [email protected]
    Phone
    856 2229988 ext. 280

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC

    Proprietary Names

    Satelec Newtron P5 XS Satelec Newtron P5 XS / P5 XS B.LED Newtron P5 XS B.LED Satelec Newtron P5 XS B.LED Newtron P5 XS Endo Tips - ETBD, ET18D, ET20D, ET40D, ET25S, ET25, ET25L EDGESURGICALTIP - #1, #2, #3, #4, #5, #6 Surgical Tips - AS3D, P15LD, ASLD, P15RD, ASRD EDGETIP - #1, #2, #3, #4, #5, #6, #7, #8

    Establishment Types

    Manufacture Medical Device