BEUDAMED
    FDA Registration Active 🇺🇸 United States

    823-803

    Reg #: 3002865830 · FEI: 3002865830 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GENERAL ASSEMBLY & MANUFACTURING CORP.
    Registration Number
    3002865830
    FEI Number
    3002865830
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    750 INDUSTRIAL DR STE B
    City
    Cary
    State
    IL
    ZIP
    60013
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042828

    Owner / Operator

    Firm Name
    GENERAL ASSEMBLY & MFG. CORP.
    Operator Number
    9038280
    Address
    750 INDUSTRIAL DR., --
    City
    Cary
    State
    IL
    Postal Code
    60013
    Country
    US
    Correspondent
    Alex Nadtochiy

    Products

    Device Name Product Code
    Plugger, Root Canal, Endodontic EKR

    Proprietary Names

    823-803 823-810 823-800

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)