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510(k) Data Aggregation

    K Number
    K092827
    Device Name
    DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
    Manufacturer
    DIMEDA INSTRUMENTE GMBH
    Date Cleared
    2010-01-08

    (116 days)

    Product Code
    HDA
    Regulation Number
    884.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIMEDA INSTRUMENTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for: - 0 prolonged second stage - 0 suspicion of immediate or potential fetal compromise - shortening of the second stage for maternal benefit 0
    Device Description
    The Dimeda Obstetrical Forceps is a surgical medical device for medical procedure to grasp the fetal head when it is in the vagina and bring about delivery by traction and guidance without causing injury to the mother or baby. The forceps consists of two arms which are movable. The device is manufactured from surgical stainless steel.
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