BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Park’s Pectus System

    Reg #: 3017609305 · FEI: 3017609305 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRIMEMED INC.
    Registration Number
    3017609305
    FEI Number
    3017609305
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    107 Intium, 1244 Sungnamdaero, Sujung-gu,
    City
    Sungnam-city Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K191057

    Owner / Operator

    Firm Name
    Primemed Inc.
    Operator Number
    10088830
    Address
    107 Intium, 1244 Sungnamdaero, Sujung-gu,
    City
    Sungnam-city
    State
    Gyeonggi
    Postal Code
    13311
    Country
    KR
    Correspondent
    Sung Dae Nam

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    Park’s Pectus System

    Establishment Types

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