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

    LABELING FOR MYO/WIRE II STERNOTOMY SUTURES

    K Number: K932513 · Decision Jan 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    227

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    Basic Information

    Device Name
    LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
    K Number
    K932513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alto Development Corp.
    Date Received
    May 25, 1993
    Decision Date
    January 7, 1994
    Product Code
    GAO
    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
    GAO Suture, Nonabsorbable

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    K884783 RANEY CLIP
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