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

    PARALLEL BLADE MARKER

    K Number: K780991 · Decision Oct 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    20
    Applicant Total
    5
    Review Days
    111

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    Basic Information

    Device Name
    PARALLEL BLADE MARKER
    K Number
    K780991
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Nestor Engineering Associates, Inc.
    Date Received
    June 14, 1978
    Decision Date
    October 3, 1978
    Product Code
    EMF
    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
    EMF Knife, Surgical

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    Other Clearances by Nestor Engineering Associates, Inc.

    K Number Device Name
    K780989 DEVIN-NESTOR SQUARE KNIFE
    K780990 STAINLESS STEEL TEMPLATE
    K780988 DEVIN-NESTOR PNEUMATIC TOURNIQUET
    K780992 MILLARD MOUTH GAG