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

    GENTLE FEEL

    K Number: K864176 · Decision Nov 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    GENTLE FEEL
    K Number
    K864176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mali, Inc.
    Date Received
    October 24, 1986
    Decision Date
    November 4, 1986
    Product Code
    HFS
    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
    HFS Shield, Nipple

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