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510(k) Data Aggregation

    K Number
    K972178
    Device Name
    UNISURGE INTERFACE P
    Manufacturer
    UNISURGE HOLDING, INC.
    Date Cleared
    1997-09-05

    (87 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNISURGE HOLDING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNISURGE Interface Controller - P is indicated for use in procedures (endo in which the UNIGRIP is used... The Interface Controller with pump is not designed to deliver any type of blood, blood products, or analgesics. It is designed for the administration of sterile irrigation fluid via sterile deposable tubing
    Device Description
    Not Found
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