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

    AGCEL WOUND DRESSING,AGCEL BURN DRESSING

    K Number: K050842 · Decision Aug 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    14
    Review Days
    488

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    Basic Information

    Device Name
    AGCEL WOUND DRESSING,AGCEL BURN DRESSING
    K Number
    K050842
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Modern Medical Equipment Mfg., Ltd.
    Date Received
    April 1, 2005
    Decision Date
    August 2, 2006
    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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