BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING

    K Number: K133775 · Decision Mar 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    104

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    Basic Information

    Device Name
    EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
    K Number
    K133775
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exciton Technologies, Inc.
    Date Received
    December 12, 2013
    Decision Date
    March 26, 2014
    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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    K103067 EXSALT SD7 WOUND DRESSING
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