BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Gown, Surgical, Level 4

    Reg #: 8022129 · FEI: 6499 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LAC-MAC LIMITED
    Registration Number
    8022129
    FEI Number
    6499
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    847 HIGHBURY AVE, BUILDING No. 2
    City
    LONDON Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K030536

    Owner / Operator

    Firm Name
    LAC-MAC LIMITED
    Operator Number
    8022129
    Address
    847 HIGHBURY AVE, BUILDING #2
    City
    LONDON
    State
    Ontario
    Postal Code
    N5Y 5B8
    Country
    CA

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    Gown, Surgical, Level 4 R.MOR.Tex

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device