BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇺🇸 United States

    FORMALENS 2000

    K Number: K863367 · Decision Sep 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    602
    Registration Numbers
    602
    Same Product Code
    55
    Applicant Total
    33
    Review Days
    23

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    Basic Information

    Device Name
    FORMALENS 2000
    K Number
    K863367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Vision-Sciences, Inc.
    Date Received
    September 3, 1986
    Decision Date
    September 26, 1986
    Product Code
    HQG
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQG Lens, Spectacle, Non-Custom (Prescription)

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