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FDA 510(k)

KDL SYRINGES AND NEEDLE

K-Number: K112057 · 2011-12-14

ApplicantShanghai Kindly Enterprise Dev. Group Co.,
Decision Date2011-12-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KDL SYRINGES AND NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kindly Enterprise Dev. Group Co.,. It received FDA 510(k) clearance on 2011-12-14 under 510(k) number K112057. 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 KDL SYRINGES AND NEEDLE?

KDL SYRINGES AND NEEDLE is a medical device that received FDA 510(k) clearance on 2011-12-14. The listed applicant is Shanghai Kindly Enterprise Dev. Group Co.,. The 510(k) number is K112057.

When did KDL SYRINGES AND NEEDLE receive FDA 510(k) clearance?

KDL SYRINGES AND NEEDLE received FDA 510(k) clearance on 2011-12-14, under 510(k) number K112057.

Who is the listed applicant for KDL SYRINGES AND NEEDLE?

The FDA 510(k) record lists Shanghai Kindly Enterprise Dev. Group Co., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KDL SYRINGES AND NEEDLE?

The FDA product code for KDL SYRINGES AND 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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