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

    FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000

    K Number: K863753 · Decision Oct 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    4
    Review Days
    35

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    Basic Information

    Device Name
    FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
    K Number
    K863753
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Foundations Plus, Inc.
    Date Received
    September 25, 1986
    Decision Date
    October 30, 1986
    Product Code
    KGX
    Advisory Committee
    General Hospital
    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
    KGX Tape And Bandage, Adhesive

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    Other Clearances by Foundations Plus, Inc.

    K Number Device Name
    K871138 FOUNDATIONS PLUS ABDOMINAL BAND 1100
    K864477 FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000
    K863754 FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000