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

    SUNTOUCH TOPICAL HEMOSTATIC DRESSING

    K Number: K112800 · Decision May 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    22
    Review Days
    239

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    Basic Information

    Device Name
    SUNTOUCH TOPICAL HEMOSTATIC DRESSING
    K Number
    K112800
    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
    September 27, 2011
    Decision Date
    May 23, 2012
    Product Code
    QSY
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Huizhou Foryou Medical Devices Co., Ltd.

    K Number Device Name
    K250642 LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
    K240809 LUOFUCON® Silver Collagen Dressing
    K242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
    K240485 LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
    K232796 LUOFUCON® Collagen Particles (Collagen Wound Dressing)
    K223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
    K221110 LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
    K223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
    K213598 LUOFUCON Collagen Wound Dressing
    K211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
    Search all 22 clearances from Huizhou Foryou Medical Devices Co., Ltd. →