BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACME-MONACO CORP.

    Reg #: 1293141 · FEI: 1293141 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    ACME-MONACO CORP.
    Registration Number
    1293141
    FEI Number
    1293141
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    75 Winchell Rd
    City
    NEW BRITAIN
    State
    CT
    ZIP
    06052
    Country
    US

    Regulatory Submissions

    510(k) Number
    K920884

    Owner / Operator

    Firm Name
    ACME-MONACO CORP.
    Operator Number
    1293141
    Address
    75 WINCHELL DR., --
    City
    New Britain
    State
    CT
    Postal Code
    06052
    Country
    US
    Correspondent
    REBECCA - KARABIN

    Products

    Device Name Product Code
    Guide, Surgical, Instrument FZX
    Clamp, Wire, Orthodontic ECN
    Tubes, Gastrointestinal (And Accessories) KNT
    Spring, Orthodontic ECO
    Wire, Orthodontic DZC
    Wire, Guide, Catheter DQX
    Bracket, Metal, Orthodontic EJF
    Stylet, Catheter DRB

    Proprietary Names

    MULTIPLE PRODUCTS Guidewire Multiple Acme Monaco Slidewire

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)