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

    FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000

    K Number: K864477 · Decision Dec 2, 1986
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    19

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    Basic Information

    Device Name
    FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000
    K Number
    K864477
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Foundations Plus, Inc.
    Date Received
    November 13, 1986
    Decision Date
    December 2, 1986
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Foundations Plus, Inc.

    K Number Device Name
    K871138 FOUNDATIONS PLUS ABDOMINAL BAND 1100
    K863753 FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
    K863754 FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000