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

    GEL-T CUSHION

    K Number: K960189 · Decision Feb 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    28
    Applicant Total
    19
    Review Days
    22

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    Basic Information

    Device Name
    GEL-T CUSHION
    K Number
    K960189
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3175
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Span-America Medical Systems, Inc.
    Date Received
    January 16, 1996
    Decision Date
    February 7, 1996
    Product Code
    KIC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIC Cushion, Flotation

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