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510(k) Data Aggregation

    K Number
    K000816
    Device Name
    SHARP BRAND ACUPUNCTURE NEEDLES
    Manufacturer
    Date Cleared
    2000-05-04

    (52 days)

    Product Code
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCM SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K983671
    Device Name
    NATURAL BRAND ACUPUNCTURE NEEDLES
    Manufacturer
    Date Cleared
    1999-03-04

    (136 days)

    Product Code
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    TCM SUPPLY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The acupuncture needles are devices used by licensed practitioners which are intended to pierce the ski in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    Acupuncture needles is defined as a device intended to pierce the skin in the practice of acupuncture by qualified practitioner of acupuncture as determined by the States. The subject of this 510(k) application - the Natural Brand acupuncture needles - is sterile, single use acupuncture needles.
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