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

    ELASTO-GEL CAST & SPLINT PADS

    K Number: K872488 · Decision Sep 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    ELASTO-GEL CAST & SPLINT PADS
    K Number
    K872488
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Southwest Technologies, Inc.
    Date Received
    June 23, 1987
    Decision Date
    September 21, 1987
    Product Code
    IPM
    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
    IPM Cover, Limb

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