BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERILE/DISPOSABLE HSG TRAY

    K Number: K810291 · Decision Mar 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    43

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    Basic Information

    Device Name
    STERILE/DISPOSABLE HSG TRAY
    K Number
    K810291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Unimar, Inc.
    Date Received
    February 3, 1981
    Decision Date
    March 18, 1981
    Product Code
    EYY
    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
    EYY Drape, Urological, Disposable

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