BEUDAMED
    Product Code: KYQ FDA class 3 21 CFR 880.5760

    Kit, Chemical Snake-Bite

    General Hospital

    The Chemical Snake-Bite Kit is a device used in emergency response to snake envenomation, employing chemical agents rather than purely mechanical means in the treatment or neutralization of snake bite injury. It is classified as FDA Class 3, the highest risk level, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness; PMAs were required to be filed by December 26, 1996, per 61 FR 50708 on September 27, 1996. The product code is KYQ, regulated under 21 CFR 880.5760, in the General Hospital medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KYQ
    Device Class
    FDA class 3
    Regulation Number
    880.5760
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96