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    FDA Registration Active 🇺🇸 United States

    Hobbs3950 (PL) - Flex-Ez Stylet Balloon Dilators: Colonic

    Reg #: 2246552 · FEI: 2246552 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    2246552
    FEI Number
    2246552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3459 SOUTH CLINTON AVE.
    City
    S Plainfield
    State
    NJ
    ZIP
    07080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K834413

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Dilator, Esophageal KNQ

    Proprietary Names

    Hobbs3950 (PL) - Flex-Ez Stylet Balloon Dilators: Colonic Hobbs3950 (PL) - Flex-Ez Over the Wire (OTW) Balloon Dilators: Achalasia Hobbs3950 (PL) - Dilation Balloon Catheter Olympus Swift Balloon Dilator Hobbs3950 (PL) - Achalasia Balloon Dilators (OTW) Hobbs3950 (PL) - Flex-Ez Over the Wire (OTW) Balloon Dilators: Pyloric Hobbs3950 (PL) - Biliary Dilators (OTW) Hobbs3950 (PL) - Flex-Ez Over the Wire (OTW) Balloon Dilators: Esophageal

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)