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FDA 510(k)

DISPOSABLE 1CC SYRINGE WITH LUER LOCK

K-Number: K945588 · 1995-02-10

ApplicantInterventional Therapeutics Corp.
Decision Date1995-02-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE 1CC SYRINGE WITH LUER LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K945588. 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 DISPOSABLE 1CC SYRINGE WITH LUER LOCK?

DISPOSABLE 1CC SYRINGE WITH LUER LOCK is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K945588.

When did DISPOSABLE 1CC SYRINGE WITH LUER LOCK receive FDA 510(k) clearance?

DISPOSABLE 1CC SYRINGE WITH LUER LOCK received FDA 510(k) clearance on 1995-02-10, under 510(k) number K945588.

Who is the listed applicant for DISPOSABLE 1CC SYRINGE WITH LUER LOCK?

The FDA 510(k) record lists Interventional Therapeutics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE 1CC SYRINGE WITH LUER LOCK?

The FDA product code for DISPOSABLE 1CC SYRINGE WITH LUER LOCK is FMF.

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Other records listing Interventional Therapeutics Corp. 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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