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

    LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999

    K Number: K040232 · Decision Mar 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
    K Number
    K040232
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lsi Solutions
    Date Received
    February 2, 2004
    Decision Date
    March 1, 2004
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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