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510(k) Data Aggregation

    K Number
    K964696
    Device Name
    SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
    Manufacturer
    SUNSOFT CORP.
    Date Cleared
    1997-02-20

    (90 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNSOFT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is indicated for the correction of visual acuity.
    Device Description
    The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline.
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