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FDA 510(k)

TERUMO U-100 INSULIN SYRING

K-Number: K001474 · 2000-06-09

ApplicantTerumo Medical Corp.
Decision Date2000-06-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO U-100 INSULIN SYRING is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2000-06-09 under 510(k) number K001474. 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 TERUMO U-100 INSULIN SYRING?

TERUMO U-100 INSULIN SYRING is a medical device that received FDA 510(k) clearance on 2000-06-09. The listed applicant is Terumo Medical Corp.. The 510(k) number is K001474.

When did TERUMO U-100 INSULIN SYRING receive FDA 510(k) clearance?

TERUMO U-100 INSULIN SYRING received FDA 510(k) clearance on 2000-06-09, under 510(k) number K001474.

Who is the listed applicant for TERUMO U-100 INSULIN SYRING?

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

What is the FDA product code for TERUMO U-100 INSULIN SYRING?

The FDA product code for TERUMO U-100 INSULIN SYRING is FMF.

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Other records listing Terumo Medical 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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