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

    KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES

    K Number: K946148 · Decision Feb 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    156
    Applicant Total
    318
    Review Days
    55

    Basic Information

    Device Name
    KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
    K Number
    K946148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Received
    December 16, 1994
    Decision Date
    February 9, 1995
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

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