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

    BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700

    K Number: K991637 · Decision Jun 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    24
    Review Days
    41

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    Basic Information

    Device Name
    BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700
    K Number
    K991637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Davol Inc., Sub. C. R. Bard, Inc.
    Date Received
    May 12, 1999
    Decision Date
    June 22, 1999
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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