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

    HYDRO-SPLINT A SPONGE-COMPRESS DRESS

    K Number: K843400 · Decision Oct 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    HYDRO-SPLINT A SPONGE-COMPRESS DRESS
    K Number
    K843400
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Compression Splint Products, Inc.
    Date Received
    August 30, 1984
    Decision Date
    October 24, 1984
    Product Code
    FYH
    Advisory Committee
    General, Plastic Surgery
    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
    FYH Splint, Extremity, Noninflatable, External, Sterile

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