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

    VAN DELLEN IRRIGATING CYSTOTOME

    K Number: K873163 · Decision Sep 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    81
    Same Product Code
    19
    Applicant Total
    7
    Review Days
    24

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    Basic Information

    Device Name
    VAN DELLEN IRRIGATING CYSTOTOME
    K Number
    K873163
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Van Dellen, Ltd.
    Date Received
    August 11, 1987
    Decision Date
    September 4, 1987
    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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