BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TempSure

    Reg #: 3007544634 · FEI: 3007544634 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Paragon Medical - Mansfield
    Registration Number
    3007544634
    FEI Number
    3007544634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    111 Forbes Blvd Suite 101
    City
    Mansfield
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171262

    Owner / Operator

    Firm Name
    PARAGON MEDICAL, INC.
    Operator Number
    10041165
    Address
    8 Matchett Drive
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Jim F Rogers

    Products

    Device Name Product Code
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    TempSure

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)