BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Skytron Disposable Light Handle Cover

    Reg #: 1825014 · FEI: 1825014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Skytron, LLC
    Registration Number
    1825014
    FEI Number
    1825014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5085 Corporate Exchange Blvd SE
    City
    Grand Rapids
    State
    MI
    ZIP
    49512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133554

    Owner / Operator

    Firm Name
    Skytron, LLC
    Operator Number
    9918015
    Address
    5085 Corporate Exchange Blvd SE, --
    City
    Grand Rapids
    State
    MI
    Postal Code
    49512
    Country
    US
    Correspondent
    Robert - Vreeland

    Products

    Device Name Product Code
    Light, Surgical, Accessories FTA

    Proprietary Names

    Skytron Disposable Light Handle Cover Surgical Light Control Cleanview disposable handle cover Ascend Video Integration

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility