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510(k) Data Aggregation
K Number
K012501Device Name
H.M.T. ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
2001-12-11
(130 days)
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hummingbird brand acupuncture needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Device Description
Hummingbird brand acupuncture needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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