BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SM ENG CO.,LTD,

    Reg #: 3008912461 · FEI: 3008912461 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SM ENG CO.,LTD
    Registration Number
    3008912461
    FEI Number
    3008912461
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    46, Nakdong-daero 1302beon-gil, Sasang-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K173779

    Owner / Operator

    Firm Name
    SM ENG co.,ltd.
    Operator Number
    10044758
    Address
    46,Nakdong-daero 1302beon-gil, Sasang-gu
    City
    Busan
    State
    KR-26
    Postal Code
    46910
    Country
    KR
    Correspondent
    Gil-Soo Lee

    US Agent

    Business Name
    Applied Dental, Incorporated
    Contact Name
    Vera Au
    Address
    1296 Kifer Road, Suite 608,
    City
    Sunnyvale
    State
    CA
    ZIP
    94086
    Country
    US
    Email
    [email protected]
    Phone
    408 7248832

    Products

    Device Name Product Code
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Surgical, Absorbable, Polydioxanone NEW

    Proprietary Names

    SM ENG CO.,LTD, Ez-Tcon Mono, Ez-Tcon Needle

    Establishment Types

    Manufacture Medical Device