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FDA 510(k)

TOP FINE INSULIN SYRINGE

K-Number: K063348 · 2007-03-01

ApplicantDaejin Tech Medical Manufacturing Co., Ltd.
Decision Date2007-03-01
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOP FINE INSULIN SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Daejin Tech Medical Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2007-03-01 under 510(k) number K063348. 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 TOP FINE INSULIN SYRINGE?

TOP FINE INSULIN SYRINGE is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is Daejin Tech Medical Manufacturing Co., Ltd.. The 510(k) number is K063348.

When did TOP FINE INSULIN SYRINGE receive FDA 510(k) clearance?

TOP FINE INSULIN SYRINGE received FDA 510(k) clearance on 2007-03-01, under 510(k) number K063348.

Who is the listed applicant for TOP FINE INSULIN SYRINGE?

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

What is the FDA product code for TOP FINE INSULIN SYRINGE?

The FDA product code for TOP FINE INSULIN SYRINGE is FMF.

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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Other records listing Daejin Tech Medical Manufacturing Co., 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.

K063466TOP FINE

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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