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FDA 510(k)

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2

K-Number: K093400 · 2010-04-01

ApplicantUnilife Medical Solutions Limited
Decision Date2010-04-01
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 is the device name listed in this FDA 510(k) record. The listed applicant is Unilife Medical Solutions Limited. It received FDA 510(k) clearance on 2010-04-01 under 510(k) number K093400. 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 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2?

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 is a medical device that received FDA 510(k) clearance on 2010-04-01. The listed applicant is Unilife Medical Solutions Limited. The 510(k) number is K093400.

When did 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 receive FDA 510(k) clearance?

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 received FDA 510(k) clearance on 2010-04-01, under 510(k) number K093400.

Who is the listed applicant for 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2?

The FDA 510(k) record lists Unilife Medical Solutions Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2?

The FDA product code for 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 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 Unilife Medical Solutions Limited 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.

K1009981ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1K0808771ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2

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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