BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sterilizer, Soft-Lens, Thermal, Ac-Powered

    PMA: N17367 · Supplement: S009 · Decision Mar 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sterilizer, Soft-Lens, Thermal, Ac-Powered
    Trade Name
    HYDROCURVE PATIENT DISINFECTION UNIT
    PMA Number
    N17367
    Supplement Number
    S009
    Device Class
    FDA Class 2
    Product Code
    HRD
    Generic Name
    Sterilizer, soft-lens, thermal, ac-powered
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 26, 1980
    Date Received
    February 5, 1980
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    HRD Sterilizer, Soft-Lens, Thermal, Ac-Powered