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510(k) Data Aggregation
K Number
K020880Device Name
MARKNEW PRODUCTS ACUPUNCTURE NEEDLESManufacturer
Date Cleared
2002-06-10
(84 days)
Product Code
Regulation Number
880.5580Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for Marknew Products Acupuncture Needles. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to proceed to market.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a scientific study report.
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