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FDA 510(k)

SINGER ACUPUNCTURE NEEDLES

K-Number: K974616 · 1998-02-05

ApplicantLorac, Inc.
Decision Date1998-02-05
Product CodeMQX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SINGER ACUPUNCTURE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Lorac, Inc.. It received FDA 510(k) clearance on 1998-02-05 under 510(k) number K974616. 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 SINGER ACUPUNCTURE NEEDLES?

SINGER ACUPUNCTURE NEEDLES is a medical device that received FDA 510(k) clearance on 1998-02-05. The listed applicant is Lorac, Inc.. The 510(k) number is K974616.

When did SINGER ACUPUNCTURE NEEDLES receive FDA 510(k) clearance?

SINGER ACUPUNCTURE NEEDLES received FDA 510(k) clearance on 1998-02-05, under 510(k) number K974616.

Who is the listed applicant for SINGER ACUPUNCTURE NEEDLES?

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

What is the FDA product code for SINGER ACUPUNCTURE NEEDLES?

The FDA product code for SINGER ACUPUNCTURE NEEDLES is MQX.

Related Clinical Trials

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.

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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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