BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AUTOMATIC LEAK TESTER C (ZUTR10003TG)

    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
    K093718

    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
    Bulb, Inflation, For Endoscope FCY

    Proprietary Names

    AUTOMATIC LEAK TESTER C (ZUTR10003TG) AUTO LEAK TESTER - SUCTION CUP (ZUTR10003P) AUTO LEAK TESTER POWER SUPPLY (ZUTRT1079P5PND) HANDHELD LEAK TESTER (ZUTR10002P) MEDICAL LEAK TEST ADAPT (ZUTR10001PA) AUTO LEAK TESTER- WALL MOUNT BRKT (ZUTR10003WMP)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198