BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Surgical Gown

    Reg #: 3034226814 · FEI: 3034226814 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Hilo Industries LLC
    Registration Number
    3034226814
    FEI Number
    3034226814
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7035 E Pecos Rd, Ste 1001 Bldg 1
    City
    Mesa
    State
    AZ
    ZIP
    85212
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093835

    Owner / Operator

    Firm Name
    Hilo Industries LLC
    Operator Number
    10073187
    Address
    7035 E Pecos Rd, STE 1001 Bldg 1
    City
    Mesa
    State
    AZ
    Postal Code
    85212
    Country
    US
    Correspondent
    Daniel Marquardt

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    Surgical Gown Standard Surgical Gown

    Establishment Types

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