BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOVIEW SPPHIRE LENS SET

    K Number: K971853 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    40
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    ENDOVIEW SPPHIRE LENS SET
    K Number
    K971853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1385
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Devices, Inc.
    Date Received
    May 20, 1997
    Decision Date
    August 6, 1997
    Product Code
    HJK
    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
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

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