BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sitzmarks

    Reg #: 3013973539 · FEI: 3013973539 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FERMATEX VASCULAR TECHNOLOGIES D.B.A. ADAM SPENCE
    Registration Number
    3013973539
    FEI Number
    3013973539
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1746 Route 34
    City
    Wall
    State
    NJ
    ZIP
    07727
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181750

    Owner / Operator

    Firm Name
    Spectrum Plastics Group (Fermatex Vascular Tech D.B.A Adam S
    Operator Number
    10084051
    Address
    1746 Route 34
    City
    Wall
    State
    NJ
    Postal Code
    07727
    Country
    US
    Correspondent
    Grace Perez

    Products

    Device Name Product Code
    System, Gastrointestinal Motility (Electrical) FFX

    Proprietary Names

    Sitzmarks

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)