BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Rotamax S6500KL

    Reg #: 3002105090 · FEI: 3002105090 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SABLE INDUSTRIES, INC.
    Registration Number
    3002105090
    FEI Number
    3002105090
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Campbell Avenue, Suite 5
    City
    Kitchener Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K102517

    Owner / Operator

    Firm Name
    Sable Industries, Inc.
    Operator Number
    10024322
    Address
    100 Campbell Avenue, Suite 5
    City
    Kitchener
    State
    Ontario
    Postal Code
    N2H 4X8
    Country
    CA
    Correspondent
    Jeff DaSilva

    US Agent

    Business Name
    ComplianceAcuity, Inc
    Contact Name
    Kevin Randall
    Address
    485 Clinton St, #888
    City
    Ridgeway
    State
    CO
    ZIP
    81432
    Country
    US
    Email
    [email protected]
    Phone
    303 8280844

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    Rotamax S6500KL TDC 4500 Access S4500KL TDC 6500

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)