BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Legend Pro

    Reg #: 3008753275 · FEI: 3008753275 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLLOGEN LTD
    Registration Number
    3008753275
    FEI Number
    3008753275
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Kaufman Street (main)
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K173503

    Owner / Operator

    Firm Name
    Pollogen
    Operator Number
    10038980
    Address
    6 Kaufman Str.
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6801298
    Country
    IL
    Correspondent
    Moshe Strass

    US Agent

    Business Name
    Qsite
    Contact Name
    Tova Rivnay
    Address
    77 Dorcar Rd
    City
    Newton
    State
    MA
    ZIP
    02459
    Country
    US
    Email
    [email protected]
    Phone
    512 5354930

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Legend Pro Pollogen Legend+ System GEN 36 GEN 36L GEN 36L DISPOSABLE TIP ASSY 5 PACK BK GEN 100 TriLift GEN12 DISPOSABLE TIP ASSY 5 PACK BK LP GEN 100 DISPOSABLE TIP ASSY 5 PACKED LP GEN 12 DISPOSABLE TIP ASSY LP GEN 36 DISPOSABLE TIP ASSY LP GEN 36L DISPOSABLE TIP ASSY GEN 12 Legend Pro Gen 100 tips LP GEN 12 DISPOSABLE TIP ASSY 5 PACKED GEN100 DISPOSABLE TIP ASSY 5 PACK BK LP GEN 100 DISPOSABLE TIP ASSY LP GEN 36L DISPOSABLE TIP ASSY 5 PACKED H7X7 LP GEN 36 DISPOSABLE TIP ASSY 5 PACKED LP H7X7 DISPOSABLE TIP ASSY LP H7X7 DISPOSABLE TIP ASSY 5 PACKED triFX 36 TIP ASSY 5 PACK H7X7 DISPOSABLE TIP ASSY 5 PACK BK GEN36 DISPOSABLE TIP ASSY 5 PACK BK triFX 12 TIP ASSY 5 PACK triFX 36L TIP ASSY 5 PACK triFX 100 TIP ASSY 5 PACK triFX H7X7 TIP ASSY 5 PACK

    Establishment Types

    Manufacture Medical Device