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

    KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE

    K Number: K060414 · Decision Oct 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    6
    Review Days
    249

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    Basic Information

    Device Name
    KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
    K Number
    K060414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kmi Kolster Methods, Inc.
    Date Received
    February 16, 2006
    Decision Date
    October 23, 2006
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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    K002859 SSW-STERILE SOLUTION WARMER
    K991203 IRRIGATION OR INFUSION PUMP K PUMP