BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hilo Industries LLC

    Reg #: 3034226814 · FEI: 3034226814 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Hilo Industries LLC
    Registration Number
    3034226814
    FEI Number
    3034226814
    Status
    Active
    Expiry Year
    2026
    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
    Cover, Shoe, Operating-Room FXP
    Non-Surgical Gown OEA
    Cap, Surgical FYF
    Gown, Surgical FYA
    Drape, Surgical, Exempt PUI

    Proprietary Names

    Shoe Cover Isolation Gown Surgical Cap, Single Layer Surgical Cap, Tri-Layer Surgical Gown Standard Surgical Gown Surgical Drapes

    Establishment Types

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