BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ADPTR,SCPE,PNTX TO WOLF LS (AL-WL)

    Reg #: 9610877 · FEI: 3008185830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HOYA Corporation PENTAX Lifecare Division
    Registration Number
    9610877
    FEI Number
    3008185830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tsutsujigaoka 1-1-110
    City
    Akishima-shi Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K850020

    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

    US Agent

    Business Name
    HOYA CORPORATION PENTAX DIVISION
    Contact Name
    Gurvinder Nanda
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    ZIP
    07645
    Country
    US
    Email
    [email protected]
    Phone
    201 5712318

    Products

    Device Name Product Code
    Gastroscope And Accessories, Flexible/Rigid FDS

    Proprietary Names

    ADPTR,SCPE,PNTX TO WOLF LS (AL-WL) ADPTR,SCPE,PNTX TO ACMI LS (AL-AL) VALVE, CO2/WATER (OF-B130) ADPTR,SCOPE,PNTX P-SERIES TO OLY CL20,CL (AL-OL11) O-RING SET,U/W OFB78 OFB102 FEEDING VALV (OF-B111) ADPTR,SCPE,PNTX TO STORZ LS (AL-SL) ADPTR,SCPE,PNTX TO OLY CLVU20,CLK4 LS (AL-OL10) EYESHIELD (OF-D3) ADPTR,SCPE,PNTX TO OLY ILK LS (AL-OL7) O-RING SET FOR OF-B194 (OF-B195) ADPTR,SCPE,PNTX, TO OLY OES10/20,CLK4 LS (AL-OL9) AIR / WATER C02 GAS VALVE (OF-B194) LIGHT SOURCE ADAPTER FOR OLYMPUS FIBERSC (AL-MF3) LIGHT SOURCE ADAPTER FOR OLYMPUS FIBERSC (Al-OR3) ADPTR,SCOPE,PNTX GI P- SERIES TO OLY CL2 (AL-OLG11)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility