BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN

    K Number: K073579 · Decision Aug 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    2
    Review Days
    242

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
    K Number
    K073579
    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
    Feg Textiltechnik Forschungs-Und Entwicklungsgesel
    Date Received
    December 20, 2007
    Decision Date
    August 18, 2008
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FTL), ordered by most recent decision date.

    ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Parietene™ Flat Sheet Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Onflex™ Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Bard® Mesh; Bard® Mesh Pre-Shaped

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Parietene™ Macroporous Mesh (PPM5050 )

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Feg Textiltechnik Forschungs-Und Entwicklungsgesel

    K Number Device Name
    K131530 DYNAMESH -CICAT