BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CONTROLLER (FG-1017)

    Reg #: 2518897 · FEI: 1000080301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K163684

    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
    Unit, Cryosurgical, Accessories GEH

    Proprietary Names

    CONTROLLER (FG-1017) FOCAL STANDARD CATHETER (FG-1028) FOOT PEDAL (FG-1018) 360 STANDARD CATHETER (FG-1029) 90 PEAR CATHETER (FG-1026) 90 STANDARD CATHETER (FG-1030) 180 STANDARD CATHETER (FG-1031) 360 PEAR CATHETER (FG-1025) CARTRIDGE (FG-1013) FOCAL PEAR CATHETER (FG-1024) 180 PEAR CATHETER (FG-1027)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198