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

    LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS

    K Number: K031443 · Decision Jun 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    8
    Review Days
    43

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    Basic Information

    Device Name
    LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
    K Number
    K031443
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lsi Solutions
    Date Received
    May 6, 2003
    Decision Date
    June 18, 2003
    Product Code
    NEW
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Lsi Solutions

    K Number Device Name
    K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
    K163639 LS-5 ePTFE Suture
    K040232 LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
    K024301 LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
    K011016 LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
    K981531 SUTURE PLACEMENT DEVICE AND ACCESSORIES
    K963919 LSI VIDEOSCOPIC DISPLAY SYSTEM