BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    SUNTOUCH Dental Dressing

    K Number: K173196 · Decision Jan 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    22
    Review Days
    114

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    Basic Information

    Device Name
    SUNTOUCH Dental Dressing
    K Number
    K173196
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Huizhou Foryou Medical Devices Co., Ltd.
    Date Received
    October 2, 2017
    Decision Date
    January 24, 2018
    Product Code
    OLR
    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
    OLR Oral Wound Dressing

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    K223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
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