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

    CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)

    K Number: K935491 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    26
    Applicant Total
    16
    Review Days
    94

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    Basic Information

    Device Name
    CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
    K Number
    K935491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tri-State Hospital Supply Corp.
    Date Received
    November 15, 1993
    Decision Date
    February 17, 1994
    Product Code
    HFX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFX Clamp, Circumcision

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