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

    MEPITEL NON ADHERENT SILICONE DRESSING

    K Number: K984371 · Decision Mar 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    10
    Review Days
    86

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    Basic Information

    Device Name
    MEPITEL NON ADHERENT SILICONE DRESSING
    K Number
    K984371
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care, Inc.
    Date Received
    December 7, 1998
    Decision Date
    March 3, 1999
    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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    K000901 KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
    K000906 KLINIDRAPE SURGICAL DRAPES
    K984370 HYPERGEL 20% HYPERTONIC SALINE GEL
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    K983184 MEPILEX