BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DermiSphere hDRT

    Reg #: 3036710971 · FEI: 3036710971 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    FESARIUS THERAPEUTICS
    Registration Number
    3036710971
    FEI Number
    3036710971
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    619 W 54th St
    City
    New York
    State
    NY
    ZIP
    10019
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241904

    Owner / Operator

    Firm Name
    Fesarius Therapeutics
    Operator Number
    10092987
    Address
    619 West 54th street
    City
    New York
    State
    NY
    Postal Code
    10019
    Country
    US
    Correspondent
    Tim Huntington

    Products

    Device Name Product Code
    Wound Dressing With Animal-Derived Material(S) KGN
    Mesh, Surgical FTM

    Proprietary Names

    DermiSphere hDRT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility