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

    SPB SKIN EMULSION

    K Number: K141637 · Decision Jun 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    3
    Review Days
    349

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    Basic Information

    Device Name
    SPB SKIN EMULSION
    K Number
    K141637
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotd S.A.
    Date Received
    June 19, 2014
    Decision Date
    June 3, 2015
    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 Biotd S.A.

    K Number Device Name
    K162017 Ross Ru Wound Dressing Gel
    K131176 ROSS RU SKIN DISCONTINUITIES