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510(k) Data Aggregation

    K Number
    K964848
    Device Name
    WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-01-16

    (44 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARLOW SURGICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
    Device Description
    The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.
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