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

    MODIFICATION OF CUTINOVA CAVITY DRESSING

    K Number: K984597 · Decision Mar 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    5
    Review Days
    63

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    Basic Information

    Device Name
    MODIFICATION OF CUTINOVA CAVITY DRESSING
    K Number
    K984597
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beiersdorf-Jobt, Inc.
    Date Received
    December 28, 1998
    Decision Date
    March 1, 1999
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Beiersdorf-Jobt, Inc.

    K Number Device Name
    K991570 JOBST READY-TO-WEAR ARM SLEEVES
    K984593 MODIFICATION OF CUTINOVA THIN DRESSING
    K984595 MODIFICATION OF CUTINOVA HYDRO DRESSING
    K984599 MODIFICATION OF CUTINOVA FOAM DRESSING