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

    SURG-K SURGICAL KERATOMETER

    K Number: K901553 · Decision Jul 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    108

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    Basic Information

    Device Name
    SURG-K SURGICAL KERATOMETER
    K Number
    K901553
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    The Sanborn Co.
    Date Received
    April 3, 1990
    Decision Date
    July 20, 1990
    Product Code
    HLR
    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
    HLR Keratoscope, Battery-Powered

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    Other Clearances by The Sanborn Co.

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