BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WATERBOTTLE HOLDER (EGA-7010)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PENTAX of America, Inc.
    Registration Number
    2518897
    FEI Number
    1000080301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3 Paragon Drive
    City
    MONTVALE
    State
    NJ
    ZIP
    07645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113310

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    Products

    Device Name Product Code
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX

    Proprietary Names

    WATERBOTTLE HOLDER (EGA-7010) YOKE ADAPTER, EGA-501P (EGA-7012) HIGH PRESSURE HOSE 3FT, EGA-501P (EGA-7011) CO2 INSUFFLATOR (EGA-501P) POWER CORD, EGA-500P/EGA-501P (EGA-7014) CO2 INSUFLATOR (EGA-501)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198