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

    HILL TOP CHAMBER

    K Number: K811365 · Decision Aug 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    364
    Registration Numbers
    364
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    98

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    Basic Information

    Device Name
    HILL TOP CHAMBER
    K Number
    K811365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Hill Top Research, Inc.
    Date Received
    May 14, 1981
    Decision Date
    August 20, 1981
    Product Code
    KXF
    Advisory Committee
    General Hospital
    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
    KXF Applicator, Absorbent Tipped, Non-Sterile

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