BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    K3 V1.2

    Reg #: 3015980207 · FEI: 3015980207 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
    Registration Number
    3015980207
    FEI Number
    3015980207
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    192, Haebong-ro, Danwon-gu
    City
    Ansan-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K183347

    Owner / Operator

    Firm Name
    Osstem Implant Co., Ltd. Chair Business
    Operator Number
    10050476
    Address
    192 Haebong-dong,Danwon-gu
    City
    Ansan-si
    State
    Gyeonggi
    Postal Code
    15428
    Country
    KR
    Correspondent
    Hae Sung Kim

    US Agent

    Business Name
    HIOSSEN, Inc.
    Contact Name
    Mateusz Leszczak
    Address
    85 Ben Fairless Drive
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US
    Email
    [email protected]
    Phone
    201 2660657

    Products

    Device Name Product Code
    Unit, Operative Dental EIA

    Proprietary Names

    K3 V1.2

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198