BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    BeneHold Surgical Incise Drape with CHG antimicrobial

    K Number: K202208 · Decision Jul 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    5
    Review Days
    358

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    Basic Information

    Device Name
    BeneHold Surgical Incise Drape with CHG antimicrobial
    K Number
    K202208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avery Dennison Belgie Bvba
    Date Received
    August 6, 2020
    Decision Date
    July 30, 2021
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Avery Dennison Belgie Bvba

    K Number Device Name
    K170407 BD ChloraShield IV Dressing with CHG Antimicrobial
    K152923 BD ChloraShield IV Dressing with CHG Antimicrobial
    K133764 CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
    K113836 BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)