BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cryo Balloon Ablation System

    Reg #: 3008780134 · FEI: 3008780134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pentax of America, Inc.
    Registration Number
    3008780134
    FEI Number
    3008780134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    303 Convention Way Ste 1 Ste 3
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101825

    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

    Cryo Balloon Ablation System

    Establishment Types

    Manufacture Medical Device