BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FOOTSWITCH W/INTEGRAL PNEUMATIC TUBING (90051)

    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
    K884836

    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    FOOTSWITCH W/INTEGRAL PNEUMATIC TUBING (90051) RECEPTICLE, FOOT SWITCH CGI-4000 (84153) FOOTSWITCH CABLE, FOR CGI-4000 (90048) BOTTLE, IRRIGATION W/MOUNTING SUPPORT BRACKET 500 ML (86337) RUBBER CGI-4000 FOOTSWITCH (90107) ELECTRODE, BIPOLAR PATIENT PAD, BOX OF 25 (82171) FOOTSWITCH, PNEUMATIC WATERPROOF (90047) ADAPTER, SCOPE CHANNEL FOR ENDO IRRIGATOR (84110) CARTRIDGE W/SILICONE TUBING FOR ENDO IRRIGATOR PUMP (90046) BOTTLE, IRRIGATION W/MOUNTING SUPPORT BRACKET 1000 ML (86345) TUBE, CONNECTING ENDO IRRIGATOR, BOX OF 12 (90050)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198