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

    CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER

    K Number: K894778 · Decision Dec 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    9
    Applicant Total
    152
    Review Days
    132

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    Basic Information

    Device Name
    CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
    K Number
    K894778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4150
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    July 27, 1989
    Decision Date
    December 6, 1989
    Product Code
    HBO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBO Clip, Scalp

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