BEUDAMED
    FDA Registration Active 🇨🇳 China

    RG 9.5 BALLAST TAP LONG

    Reg #: 3007539489 · FEI: 3007539489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Paragon Medical Device (Changzhou) Co., Ltd.
    Registration Number
    3007539489
    FEI Number
    3007539489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3A GDH Industrial Park, No. 16 Chuangye Road
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K182121

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    9011072
    Address
    8 Matchett Dr., --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane Langlois

    US Agent

    Business Name
    Paragon Medical
    Contact Name
    Stephane Langlois
    Address
    8 Matchett Dr
    City
    Pierceton
    State
    IN
    ZIP
    46562
    Country
    US
    Email
    [email protected]
    Phone
    435 5355456

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    RG 9.5 BALLAST TAP LONG RG 11.5 BALLAST TAP LONG RG AWL-TIP TAP LONG RG BALLAST TAP LONG RG BALLAST DRILL 4.2 x 70 LONG RG SOLERA AWL-TIP TAP SHORT RG 8.5 BALLAST TAP LONG RG DRILL 3 x 30 LONG RG 10.5 BALLAST TAP LONG RG DRILL 3 x 30 SHORT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)