BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COMBE INCORPORATED

    Reg #: 2412672 · FEI: 2412672 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COMBE INCORPORATED
    Registration Number
    2412672
    FEI Number
    2412672
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1101 Westchester Ave
    City
    White Plains
    State
    NY
    ZIP
    10604
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041432

    Owner / Operator

    Firm Name
    COMBE INCORPORATED
    Operator Number
    2412672
    Address
    1101 WESTCHESTER AVE., --
    City
    White Plains
    State
    NY
    Postal Code
    10604
    Country
    US
    Correspondent
    Richard Grabarz

    Products

    Device Name Product Code
    Condom HIS

    Establishment Types

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