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

    AQUACEL Ag Surgical SP Dressing

    K Number: K152926 · Decision Jan 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    10
    Review Days
    108

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    Basic Information

    Device Name
    AQUACEL Ag Surgical SP Dressing
    K Number
    K152926
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec Limited
    Date Received
    October 5, 2015
    Decision Date
    January 21, 2016
    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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