BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMMA

    Reg #: 3021619527 · FEI: 3021619527 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    COOLER HEADS CARE, INC.
    Registration Number
    3021619527
    FEI Number
    3021619527
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    610 Gateway Center Way, Ste G
    City
    San Diego
    State
    CA
    ZIP
    92102
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211526

    Owner / Operator

    Firm Name
    Cooler Heads Care, Inc.
    Operator Number
    10084301
    Address
    610 Gateway Center Way, Ste G
    City
    San Diego
    State
    CA
    Postal Code
    92102
    Country
    US
    Correspondent
    Kate Dilligan

    Products

    Device Name Product Code
    Scalp Cooling System PMC

    Proprietary Names

    AMMA

    Establishment Types

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