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

    TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING

    K Number: K983234 · Decision Nov 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
    K Number
    K983234
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Medical, Div. of Ethicon, Inc.
    Date Received
    September 15, 1998
    Decision Date
    November 25, 1998
    Product Code
    MGP
    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
    MGP Dressing, Wound And Burn, Occlusive

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    Other Clearances by Johnson & Johnson Medical, Div. of Ethicon, Inc.

    K Number Device Name
    K990236 MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
    K990395 BARRIER SURGICAL GOWNS
    K983240 NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
    K983394 MODIFICATION TO TIELLE HYDROPOLMER DRESSING