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

    AQUADERM

    K Number: K885205 · Decision Mar 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    6
    Review Days
    100

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    Basic Information

    Device Name
    AQUADERM
    K Number
    K885205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Laivan Corp.
    Date Received
    December 19, 1988
    Decision Date
    March 29, 1989
    Product Code
    KGX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGX Tape And Bandage, Adhesive

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