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510(k) Data Aggregation

    K Number
    K241848
    Device Name
    MedtFine Safety Lancet
    Manufacturer
    Ningbo Caremed Medical Products Co. Ltd.
    Date Cleared
    2024-08-20

    (54 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Caremed Medical Products Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The safety lancet is intended for capillary blood sampling.
    Device Description
    Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.
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