BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Atteris No-Sting Skin Protectant

    K Number: K160684 · Decision Jul 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    5
    Review Days
    137

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    Basic Information

    Device Name
    Atteris No-Sting Skin Protectant
    K Number
    K160684
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rochal Industries, LLC
    Date Received
    March 11, 2016
    Decision Date
    July 26, 2016
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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    Other Clearances by Rochal Industries, LLC

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    K192527 Rochal Antimicrobial Wound Gel
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