BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENT/NEURO/OMF System and Accessory

    Reg #: 2020550 · FEI: 2020550 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Registration Number
    2020550
    FEI Number
    2020550
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    28 Millbury Street
    City
    Auburn
    State
    MA
    ZIP
    01501
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053262

    Owner / Operator

    Firm Name
    KARL STORZ SE & CO KG
    Operator Number
    8010119
    Address
    Dr.-Karl-Storz-Strasse 34,
    City
    TUTTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    78532
    Country
    DE

    Products

    Device Name Product Code
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    ENT/NEURO/OMF System and Accessory

    Establishment Types

    Repack or Relabel Medical Device