BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lens, Contact (Other Material) - Daily

    PMA: P870024 · Supplement: S041 · Decision Aug 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Lens, Contact (Other Material) - Daily
    Trade Name
    FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES
    PMA Number
    P870024
    Supplement Number
    S041
    Device Class
    FDA Class 2
    Product Code
    HQD
    Generic Name
    Lens, contact (other material) - daily
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 25, 1997
    Date Received
    May 12, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Viscon Contact Lens Manufacturing Ltd., 10214-112 Street, Edmonton, Alberta, Canada T5K1M4, as an alternate manufacturing and distribution site for the device.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQD Lens, Contact (Other Material) - Daily