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510(k) Data Aggregation

    K Number
    K062332
    Device Name
    ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
    Date Cleared
    2007-04-25

    (258 days)

    Product Code
    Regulation Number
    886.5928
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTAIRE PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
    Device Description
    Altaire MPS#1 Multipurpose Contact Lens Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127, cremophor RH40and preserved with edetate disodium dehydrate 0.025% and polyhexanide 0.0001%
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