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FDA 510(k)

SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

K-Number: K111841 · 2012-03-01

ApplicantChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.
Decision Date2012-03-01
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.. It received FDA 510(k) clearance on 2012-03-01 under 510(k) number K111841. 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 SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE?

SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE is a medical device that received FDA 510(k) clearance on 2012-03-01. The listed applicant is Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.. The 510(k) number is K111841.

When did SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE receive FDA 510(k) clearance?

SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE received FDA 510(k) clearance on 2012-03-01, under 510(k) number K111841.

Who is the listed applicant for SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE?

The FDA 510(k) record lists Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE?

The FDA product code for SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT 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

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

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