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510(k) Data Aggregation
K Number
K000816Device Name
SHARP BRAND ACUPUNCTURE NEEDLES
Manufacturer
Date Cleared
2000-05-04
(52 days)
Product Code
Regulation Number
880.5580Why 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
K983671Device Name
NATURAL BRAND ACUPUNCTURE NEEDLES
Manufacturer
Date Cleared
1999-03-04
(136 days)
Regulation Number
880.5580Why 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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