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

    MANI NEEDLE & SUTURE PACK (SILK)

    K Number: K053638 · Decision May 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    40
    Applicant Total
    4
    Review Days
    141

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    Basic Information

    Device Name
    MANI NEEDLE & SUTURE PACK (SILK)
    K Number
    K053638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5030
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mani, Inc.
    Date Received
    December 29, 2005
    Decision Date
    May 19, 2006
    Product Code
    GAP
    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
    GAP Suture, Nonabsorbable, Silk

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    Other Clearances by Mani, Inc.

    K Number Device Name
    K053637 MANI NEEDLE & SUTURE PACK (NYLON)
    K053636 MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
    K050150 MANI NEEDLE & SUTURE PACK