BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SoloFit Surgical Gown

    Reg #: 3017838287 · FEI: 3017838287 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OPERATING ROOM INNOVATIONS, INC
    Registration Number
    3017838287
    FEI Number
    3017838287
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2223 Avenida De La Playa, Suite 104
    City
    La Jolla
    State
    CA
    ZIP
    92037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101593

    Owner / Operator

    Firm Name
    Operating Room Innovations, Inc
    Operator Number
    10079868
    Address
    2223 Avenida De La Playa, Suite 104
    City
    La Jolla
    State
    CA
    Postal Code
    92037
    Country
    US
    Correspondent
    Sebastian Feye

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    SoloFit Surgical Gown

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility