BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇧🇪 Belgium

    BD ChloraShield IV Dressing with CHG Antimicrobial

    K Number: K170407 · Decision Jul 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    5
    Review Days
    157

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    Basic Information

    Device Name
    BD ChloraShield IV Dressing with CHG Antimicrobial
    K Number
    K170407
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avery Dennison Belgie Bvba
    Date Received
    February 10, 2017
    Decision Date
    July 17, 2017
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by Avery Dennison Belgie Bvba

    K Number Device Name
    K202208 BeneHold Surgical Incise Drape 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)