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

    MECHANICAL CYSTITOME

    K Number: K862709 · Decision Aug 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    81
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    MECHANICAL CYSTITOME
    K Number
    K862709
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Rudolph Beaver, Inc.
    Date Received
    July 16, 1986
    Decision Date
    August 1, 1986
    Product Code
    HNY
    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
    HNY Cystotome

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