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FDA 510(k)

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE

K-Number: K061039 · 2006-06-29

ApplicantAmsino International, Inc.
Decision Date2006-06-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2006-06-29 under 510(k) number K061039. 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 AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE?

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE is a medical device that received FDA 510(k) clearance on 2006-06-29. The listed applicant is Amsino International, Inc.. The 510(k) number is K061039.

When did AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE receive FDA 510(k) clearance?

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE received FDA 510(k) clearance on 2006-06-29, under 510(k) number K061039.

Who is the listed applicant for AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE?

The FDA 510(k) record lists Amsino International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE?

The FDA product code for AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE is FMF.

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Other records listing Amsino International, Inc. as applicant

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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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