BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kimono MicroThin Large

    Reg #: 2938651 · FEI: 2938651 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MAYER LABORATORIES
    Registration Number
    2938651
    FEI Number
    2938651
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1400 Shattuck Ave., Suite 9
    City
    Berkeley
    State
    CA
    ZIP
    94709
    Country
    US

    Regulatory Submissions

    510(k) Number
    K946376

    Owner / Operator

    Firm Name
    MAYER LABORATORIES
    Operator Number
    2938651
    Address
    1400 Shattuck Ave, Suite 9
    City
    Berkeley
    State
    CA
    Postal Code
    94709
    Country
    US
    Correspondent
    DAVID P MAYER

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    Kimono MicroThin Large Kimono MicroThin Variety Pack Kimono MAXX

    Establishment Types

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