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

    KTI HY-Q(TM) WOUND DRESSING

    K Number: K940738 · Decision May 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    KTI HY-Q(TM) WOUND DRESSING
    K Number
    K940738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kingston Technologies, Inc.
    Date Received
    February 17, 1994
    Decision Date
    May 6, 1994
    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 Kingston Technologies, Inc.

    K Number Device Name
    K935232 HYDROTORQUE GUIDE WIRE
    K940814 HYDRO-M(TM) WOUND GEL
    K925660 KTI TRANSPARENT WOUND DRESSING
    K921502 HYSORB WOUND DRESSING
    K882157 PANAMEX(TM) URETERAL STENT