BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RE-SHARPENABLE SAW BLADES

    K Number: K940501 · Decision Jun 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    299
    Registration Numbers
    299
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    146

    Basic Information

    Device Name
    RE-SHARPENABLE SAW BLADES
    K Number
    K940501
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVEN MEDICAL
    Date Received
    February 2, 1994
    Decision Date
    June 28, 1994
    Product Code
    GFA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GFA Blade, Saw, General & Plastic Surgery, Surgical

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    Other Clearances by ADVEN MEDICAL

    K Number Device Name
    K021528 REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
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    K012675 REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
    K012676 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
    K012694 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS