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FDA 510(k)

JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE

K-Number: K124037 · 2013-09-12

ApplicantJung Rim Medical Industrial Co., Ltd.
Decision Date2013-09-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Jung Rim Medical Industrial Co., Ltd.. It received FDA 510(k) clearance on 2013-09-12 under 510(k) number K124037. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE?

JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE is a medical device that received FDA 510(k) clearance on 2013-09-12. The listed applicant is Jung Rim Medical Industrial Co., Ltd.. The 510(k) number is K124037.

When did JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE receive FDA 510(k) clearance?

JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE received FDA 510(k) clearance on 2013-09-12, under 510(k) number K124037.

Who is the listed applicant for JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE?

The FDA 510(k) record lists Jung Rim Medical Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE?

The FDA product code for JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE is FMF.

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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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