BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ScanX Barrier Envelope: G8511-0, G8511-1, G8511-2, G8511-2k, G8511-3, G8511-4

    Reg #: 3001468798 · FEI: 2000020733 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MACO BAG CORP.
    Registration Number
    3001468798
    FEI Number
    2000020733
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    412 van Buren St
    City
    Newark
    State
    NY
    ZIP
    14513
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190949

    Owner / Operator

    Firm Name
    MACO BAG CORP.
    Operator Number
    1316093
    Address
    412 Van Buren Street
    City
    Newark
    State
    NY
    Postal Code
    14513
    Country
    US
    Correspondent
    Mike Miller

    Products

    Device Name Product Code
    Dental Barriers And Sleeves PEM

    Proprietary Names

    ScanX Barrier Envelope: G8511-0, G8511-1, G8511-2, G8511-2k, G8511-3, G8511-4 ScanX Barrier Envelopes: 73248-0, 73248-1, 73248-2, 73248-2k, 73248-3, 73248-4.

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)