BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORCA

    Reg #: 3006076009 · FEI: 3006076009 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOVAC PRODUCTS LLC
    Registration Number
    3006076009
    FEI Number
    3006076009
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1306 Enterprise Dr Ste C
    City
    ROMEOVILLE
    State
    IL
    ZIP
    60446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163223

    Owner / Operator

    Firm Name
    ISOVAC PRODUCTS LLC
    Operator Number
    9070989
    Address
    1306 ENTERPRISE DR., UNIT A
    City
    Romeoville
    State
    IL
    Postal Code
    60446
    Country
    US
    Correspondent
    Chris Schultz

    Products

    Device Name Product Code
    Chamber, Patient Isolation LGM

    Proprietary Names

    ORCA CAPSULS

    Establishment Types

    Manufacture Medical Device