BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT

    K Number: K870518 · Decision Apr 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    29
    Review Days
    83

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    Basic Information

    Device Name
    SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
    K Number
    K870518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Surgitek
    Date Received
    February 5, 1987
    Decision Date
    April 29, 1987
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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