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

    MEPILEX

    K Number: K983184 · Decision Oct 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    10
    Review Days
    47

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    Basic Information

    Device Name
    MEPILEX
    K Number
    K983184
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care, Inc.
    Date Received
    September 11, 1998
    Decision Date
    October 28, 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 Molnlycke Health Care, Inc.

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    K051625 BARRIER SURGICAL DRAPES
    K000902 KLINIDRAPE REINFORCED SURGICAL GOWNS
    K000901 KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
    K000906 KLINIDRAPE SURGICAL DRAPES
    K984371 MEPITEL NON ADHERENT SILICONE DRESSING
    K984370 HYPERGEL 20% HYPERTONIC SALINE GEL
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    K983554 ALLDRESS, ABSORBENT FILM DRESSING