BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KELO-COTE; SCAR AWAY SCAR REPAIR GEL

    Reg #: 3005779557 · FEI: 3005779557 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FORMULATED SOLUTIONS, LLC
    Registration Number
    3005779557
    FEI Number
    3005779557
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11775 Starkey Road
    City
    Largo
    State
    FL
    ZIP
    33773
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002488

    Owner / Operator

    Firm Name
    Formulated Solutions, LLC
    Operator Number
    10033613
    Address
    11775 Starkey Road
    City
    Largo
    State
    FL
    Postal Code
    33773
    Country
    US

    Products

    Device Name Product Code
    Elastomer, Silicone, For Scar Management MDA

    Proprietary Names

    KELO-COTE; SCAR AWAY SCAR REPAIR GEL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)