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

    MITRASHEER TRANSPLANT DRESSING

    K Number: K911649 · Decision Aug 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    5
    Review Days
    117

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    Basic Information

    Device Name
    MITRASHEER TRANSPLANT DRESSING
    K Number
    K911649
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Polymint Industrial Co. , Ltd.
    Date Received
    April 12, 1991
    Decision Date
    August 7, 1991
    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 Polymint Industrial Co. , Ltd.

    K Number Device Name
    K932457 SPYROGEL WOUND DRESSING
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    K891644 SAMBORD LATEX PATIENT EXAMINATION GLOVES