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FDA 510(k)

FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE

K-Number: K031818 · 2003-12-03

ApplicantFacilai Enterprises , Ltd.
Decision Date2003-12-03
Product CodeMQX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Facilai Enterprises , Ltd.. It received FDA 510(k) clearance on 2003-12-03 under 510(k) number K031818. The device is classified under product code MQX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE?

FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE is a medical device that received FDA 510(k) clearance on 2003-12-03. The listed applicant is Facilai Enterprises , Ltd.. The 510(k) number is K031818.

When did FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE receive FDA 510(k) clearance?

FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE received FDA 510(k) clearance on 2003-12-03, under 510(k) number K031818.

Who is the listed applicant for FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE?

The FDA 510(k) record lists Facilai Enterprises , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE?

The FDA product code for FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE is MQX.

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Related Devices (Code: MQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162566AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd.K132896CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBEAsia-Med GmbH and CO KGK111392WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)Woojeon CompanyK103061BIOMATE STERILE ACUPUNCTURE NEEDLEBiomate Medical Devices Technology Co., Ltd.K092240ACUPUNCTURE NEEDLESHaenglim Seowon Medical Co.K090199JIAJIAN ACUPUNCTURE NEEDLEWuxi Jiajian Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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