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

    LAMINARIA

    K Number: K881312 · Decision May 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    31
    Review Days
    56

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    Basic Information

    Device Name
    LAMINARIA
    K Number
    K881312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4260
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    March 28, 1988
    Decision Date
    May 23, 1988
    Product Code
    HDY
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDY Dilator, Cervical, Hygroscopic-Laminaria

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