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510(k) Data Aggregation

    K Number
    K122122
    Device Name
    REGEN SPRAY APPLICATOR,
    Manufacturer
    REGEN LAB SA
    Date Cleared
    2012-11-09

    (115 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGEN LAB SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is designed for use in applying two non-homogeneous fluids or liquids to a treatment site as deemed necessary by the clinical use requirements. Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is for single use only.
    Device Description
    The Regen Spray Applicator (models R-A/NAC) & R-A/NAC3) is a self-contained disposable kit aiding to simultaneous delivery of two non-homogeneous fluids or liguids to a treatment site-as deemed necessary by the clinical use requirements. The Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is comprised of sterile disposable needles, syringe holder, double piston stopper, nozzle, and syringes.
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