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510(k) Data Aggregation
K Number
K021095Device Name
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
Manufacturer
Date Cleared
2002-05-17
(43 days)
Product Code
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Device Description
The Holy Dragon Brand Acupuncture Needles are sterile disposable, surgical stainless steel with a spiral wound silver or copper handle that is mechanically attached. The needles are supplied individually blister sealed packaged with polypropylene insertion tubes and medical grade paper. They are sold in paper carton boxes in quantities of either 100 or 500 needles per box. Statements "For single use only," "Federal law restricts this device to sale by or on the order of qualified practitioners of acupuncture as determined by the States," "Pyrogen Free," and "made in China" are shown in box labeling.
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