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

    BIOPATCH ANTIMICROBIAL DRESSING

    K Number: K003229 · Decision Oct 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    2
    Applicant Total
    29
    Review Days
    381

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    Basic Information

    Device Name
    BIOPATCH ANTIMICROBIAL DRESSING
    K Number
    K003229
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Corp.
    Date Received
    October 10, 2000
    Decision Date
    October 26, 2001
    Product Code
    SEL
    Advisory Committee
    Unknown
    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
    SEL Securement Wound Dressing For Reduction Of Infection

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