BEUDAMED
    FDA Registration Active 🇹🇷 Türkiye

    Access and Dissector System

    Reg #: 3014461810 · FEI: 3014461810 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BURAK GLOBAL IC VE DIS TIC LTD STI
    Registration Number
    3014461810
    FEI Number
    3014461810
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sahabiye Mh. Ahmet Pasa Cd., Ahmet Pasa Is Merk. No: 16/701
    City
    Kocasinan Kayseri
    Country
    TR

    Regulatory Submissions

    510(k) Number
    K151356

    Owner / Operator

    Firm Name
    BURAK GLOBAL IC VE DIS TIC LTD STI
    Operator Number
    10058392
    Address
    Sahabiye Mh. Ahmet Pasa Cd., Ahmet Pasa Is Merk. No: 16/701
    City
    Kocasinan
    State
    Kayseri
    Postal Code
    38015
    Country
    TR
    Correspondent
    Hayati ERTUGRUL

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Access and Dissector System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device