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

    HEMO-O-LOK

    K Number: K941972 · Decision Jun 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    112
    Registration Numbers
    112
    Same Product Code
    175
    Applicant Total
    7
    Review Days
    68

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    Basic Information

    Device Name
    HEMO-O-LOK
    K Number
    K941972
    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
    King & Spalding
    Date Received
    April 22, 1994
    Decision Date
    June 29, 1994
    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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