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

    Saline Wound Wash, SteriCleanse(TM)

    K Number: K183662 · Decision Sep 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    1
    Review Days
    259

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    Basic Information

    Device Name
    Saline Wound Wash, SteriCleanse(TM)
    K Number
    K183662
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascent Consumer Products, Inc.
    Date Received
    December 27, 2018
    Decision Date
    September 12, 2019
    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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