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FDA 510(k)

Sterile Hypodermic Safety Syringes for Single Use

K-Number: K163162 · 2017-03-20

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.
Decision Date2017-03-20
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Safety Syringes for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163162. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Hypodermic Safety Syringes for Single Use?

Sterile Hypodermic Safety Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163162.

When did Sterile Hypodermic Safety Syringes for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Safety Syringes for Single Use received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163162.

Who is the listed applicant for Sterile Hypodermic Safety Syringes for Single Use?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Safety Syringes for Single Use?

The FDA product code for Sterile Hypodermic Safety Syringes for Single Use is MEG.

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Other records listing Jiangxi Hongda Medical Equipment Group , Ltd. as applicant

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.

K211753Sterile Syringe With Safety NeedleK210622Single-Use Medical Face MaskK210578Medical Nitrile Examination Gloves (Power free, Blue)K210821Medical PVC Examination GlovesK163160Sterile Single-use Infusion SetK163161Sterile Single-use Syringe with Needle

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Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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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