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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

    K Number: K012456 · Decision Sep 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    90
    Applicant Total
    6
    Review Days
    51

    Basic Information

    Device Name
    SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
    K Number
    K012456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SODEM SYSTEMS
    Date Received
    August 1, 2001
    Decision Date
    September 21, 2001
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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    Other Clearances by SODEM SYSTEMS

    K Number Device Name
    K023070 SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K023066 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
    K012457 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
    K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
    K994175 MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE