BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Accessories, Soft Lens Products

    PMA: P870007 · Supplement: S010 · Decision Apr 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Accessories, Soft Lens Products
    Trade Name
    SORBIC ACID PRESERVED SALINE SOL.PH CHANGE
    PMA Number
    P870007
    Supplement Number
    S010
    Device Class
    FDA Class 2
    Product Code
    LPN
    Generic Name
    Accessories, soft lens products
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 22, 1996
    Date Received
    October 3, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TRANSFER OF THE PROCESSING SITE FOR 100 PERCENT ETHYLENE OXIDE (ETO) STERILIZATION OF PLASTIC CONTAINERS, TIPS AND CLOSURES USED IN THE MANUFACTURE OF SORBIC ACID PRESERVED STERILE SALINE FOR SOFT CONTACT LENSES. THE ETO STERILIZATION FACILITY IS GRIFFITH MICROSCIENCE GLEN FALLS FACILITY, LOCATED IN GLEN FALLS, NY

    Classifications

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

    Product Code Device Name
    LPN Accessories, Soft Lens Products