LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K991625
    Device Name
    KOMET XK-95 PERFORATOR MOTOR (MI-102)
    Manufacturer
    KOMET MEDICAL
    Date Cleared
    1999-07-30

    (80 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOMET MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XK-95 Perforator Motor is intended to be used in conjunction with various cranial The XX-95 I criorator Motor adapter for cranial perforations.
    Device Description
    Not Found
    Ask a Question
    K Number
    K984035
    Device Name
    XK-95 HIGH SPEED MOTOR DRILL SYSTEM
    Manufacturer
    KOMET MEDICAL
    Date Cleared
    1999-06-03

    (203 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOMET MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1