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

    SELF-LATCHING CLIP

    K Number: K945231 · Decision Jan 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    175
    Applicant Total
    1
    Review Days
    92

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    Basic Information

    Device Name
    SELF-LATCHING CLIP
    K Number
    K945231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical System, Inc.
    Date Received
    October 27, 1994
    Decision Date
    January 27, 1995
    Product Code
    FZP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZP Clip, Implantable

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