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510(k) Data Aggregation

    K Number
    K991216
    Device Name
    HOFFMAN IVF-1
    Manufacturer
    (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION
    Date Cleared
    1999-08-05

    (118 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To maintain a temperature and pH in an enclosed device for oocyte screening, fertilization identification, cleavage check and embryo transfer.
    Device Description
    Not Found
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