BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Mygen™ V-1000 RF Generator

    Reg #: 3015136673 · FEI: 3015136673 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    RF MEDICAL CO., LTD
    Registration Number
    3015136673
    FEI Number
    3015136673
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K180999

    Owner / Operator

    Firm Name
    RF MEDICAL CO., LTD
    Operator Number
    10059293
    Address
    #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08513
    Country
    KR
    Correspondent
    Kwang Sun Choi

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St. Suite 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

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

    Proprietary Names

    Mygen™ V-1000 RF Generator THYBLATE™ (RFTS 07XXLN) THYBLATE™ (RFTS 07XX) THYBLATE™ (RFTSP 10XXN) THYBLATE™ (RFT 07XXN) THYBLATE™ (RFT 07XXL) THYBLATE™ (RFT 07XXHLN) THYBLATE™ (RFTP 10XXN) THYBLATE™ (RFT 07XXHN) THYBLATE™ (RFTP 07XXHN) THYBLATE™ (RFTSP 07XXLN) THYBLATE™ (RFT 10XXHLN) THYBLATE™ (RFTP 10XXHLN) THYBLATE™ (RFT 10XXLN) THYBLATE™ (RFTP 07XXN) THYBLATE™ (RFTSP 07XXN) THYBLATE™ (RFT 10XXL) THYBLATE™ (RFT 07XXLN) THYBLATE™ (RFT 10XXHL) THYBLATE™ (RFTP 10XXLN) THYBLATE™ (RFT 07XX) THYBLATE™ (RFTS 07XXL) THYBLATE™ (RFTP 07XXLN) THYBLATE™ (RFTP 10XXHL) THYBLATE™ (RFTS 07XXN) THYBLATE™ (RFT 10XXN) THYBLATE™ (RFT 10XX) THYBLATE™ (RFTP 10XXHN) THYBLATE™ (RFT 07XXHL) THYBLATE™ (RFT 07XXH) THYBLATE™ (RFTP 07XXHL) THYBLATE™ (RFTP 07XXHLN) THYBLATE™ (RFT 10XXHN) THYBLATE™ (RFTSP 10XXLN)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198