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510(k) Data Aggregation

    K Number
    K970916
    Device Name
    H.V. PULSE LAVAGE (L31 SERIES)
    Date Cleared
    1997-06-20

    (100 days)

    Product Code
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tava Surgical Instruments' L31 Series H.V. Pulse Lavage is intended to be utilized in the debridement of the surgical site during trauma cases, hip and knee arthroplasty cases and soft tissue surgery.
    Device Description
    Tava Surgical Instruments' L31 H.V. Pulse Lavage is an ergonomically designed pneumatic instrument. The hatch of the cradle is raised in order to insert single-use sterile pump sets which isolates the sterile fluids from the instrument. Activation of the instrument causes engagement of the pump set and pulsates the sterile fluids into the surgical site to remove blood and debris.
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