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

    CARDIOVASCULAR SAW BLADES

    K Number: K830189 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    CARDIOVASCULAR SAW BLADES
    K Number
    K830189
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Temp Medical Products, Inc.
    Date Received
    January 19, 1983
    Decision Date
    March 24, 1983
    Product Code
    DWH
    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
    DWH Blade, Saw, Surgical, Cardiovascular

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    Other Clearances by Temp Medical Products, Inc.

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