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

    MODIFICATION TO FLUOROTEX II SURGICAL MESH

    K Number: K003917 · Decision Jan 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    7
    Review Days
    38

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    Basic Information

    Device Name
    MODIFICATION TO FLUOROTEX II SURGICAL MESH
    K Number
    K003917
    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
    Bridger Biomed, Inc.
    Date Received
    December 19, 2000
    Decision Date
    January 26, 2001
    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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    Other Clearances by Bridger Biomed, Inc.

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    K984197 FLUOROTEX SURGICAL MESH
    K980548 DURA-PATCH MODEL DP-XXX
    K973178 FLUORO-TEX SURGICAL MEMBRANE