BEUDAMED
    FDA Registration Active 🇭🇳 Honduras

    Aero Chrome Breathable Performance Surgical Gown

    Reg #: 9680646 · FEI: 1000582923 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    O&M Halyard Honduras S.A de C.V.
    Registration Number
    9680646
    FEI Number
    1000582923
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARRETERA TEGUCIGALPA,
    City
    VILLANEVA Cortes
    Country
    HN

    Regulatory Submissions

    510(k) Number
    K200522

    Owner / Operator

    Firm Name
    O&M Halyard, Inc.
    Operator Number
    10057479
    Address
    1220 Old Alpharetta Rd, Suite 320
    City
    Alpharetta
    State
    GA
    Postal Code
    30005
    Country
    US
    Correspondent
    Angela Bunn

    US Agent

    Business Name
    O&M HALYARD, INC.
    Contact Name
    Angela Bunn
    Address
    1220 Old Alpharetta Rd Ste 320
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    770 4011697

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    Aero Chrome Breathable Performance Surgical Gown

    Establishment Types

    Manufacture Medical Device