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

    CKS OSCILLATING SAW BLADE

    K Number: K921131 · Decision Jun 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    379
    Registration Numbers
    379
    Same Product Code
    75
    Applicant Total
    31
    Review Days
    90

    Basic Information

    Device Name
    CKS OSCILLATING SAW BLADE
    K Number
    K921131
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TECHMEDICA, INC.
    Date Received
    March 10, 1992
    Decision Date
    June 8, 1992
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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