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FDA 510(k)

EVICEL APPLICATION DEVICE

K-Number: K090162 · 2009-02-20

ApplicantOmrix Biopharmaceuticals , Ltd.
Decision Date2009-02-20
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EVICEL APPLICATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Omrix Biopharmaceuticals , Ltd.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K090162. 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 EVICEL APPLICATION DEVICE?

EVICEL APPLICATION DEVICE is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Omrix Biopharmaceuticals , Ltd.. The 510(k) number is K090162.

When did EVICEL APPLICATION DEVICE receive FDA 510(k) clearance?

EVICEL APPLICATION DEVICE received FDA 510(k) clearance on 2009-02-20, under 510(k) number K090162.

Who is the listed applicant for EVICEL APPLICATION DEVICE?

The FDA 510(k) record lists Omrix Biopharmaceuticals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVICEL APPLICATION DEVICE?

The FDA product code for EVICEL APPLICATION DEVICE 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 Omrix Biopharmaceuticals , 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.

K070575EVICEL APPLICATION DEVICE

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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